Pre-tied surgical knots for use with suture passers

ABSTRACT

Sutures with pre-tied knots for use in percutaneous surgical procedures and devices for easily and quickly tying complex suture knots are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims priority as a continuation to U.S. patentapplication Ser. No. 15/132,211 filed Apr. 18, 2016, which claimspriority as a continuation-in-part to U.S. patent application Ser. No.13/758,994, filed on Feb. 4, 2013 and titled “PRE-TIED SURGICAL KNOTSFOR USE WITH SUTURE PASSERS, now U.S. Pat. No. 9,314,234 which claimspriority to U.S. Provisional Patent Application No. 61/698,528, filed onSep. 7, 2012 and titled “PRE-TIED SURGICAL KNOTS FOR USE WITH SUTUREPASSERS.”

This patent application also claims priority to U.S. Provisional PatentApplication No. 62/236,758, filed Oct. 2, 2015 and titled “KNOT TYINGACCESSORY”. Each of these patent applications is herein incorporated byreference in its entirety.

The pre-tied knots described herein may be used, in particular, with, oras part of any of the suture passer devices and systems described in thefollowing patent applications, each of which is herein incorporated byreference in its entirety. Specifically: U.S. patent application Ser.No. 11/773,388, filed on Jul. 3, 2007, titled “METHODS AND DEVICES FORCONTINUOUS SUTURE PASSING,” now Publication No. US-2009-0012538-A1; U.S.patent application Ser. No. 12/972,222, filed on Dec. 17, 2010, titled“METHODS AND DEVICES FOR CONTINUOUS SUTURE PASSING,” now Publication No.US-2011-0087246-A1; U.S. patent application Ser. No. 13/462,760, filedon May 2, 2012, titled “METHODS OF MENISCUS REPAIR,” now Publication No.US-2012-0239062-A1; U.S. patent application Ser. No. 13/006,966, filedon Jan. 14, 2011, titled “METHODS FOR CONTINUOUS SUTURE PASSING,” nowPublication No. US-2011-0130773-A1; U.S. patent application Ser. No.13/090,089, filed on Apr. 19, 2011, titled “METHODS OF MENISCUS REPAIR,”now Publication No. US-2011-0218557-A1; U.S. patent application Ser. No.12/291,159, filed on Nov. 5, 2008, titled “SUTURE PASSING INSTRUMENT ANDMETHOD,” now Publication No. US-2010-0331863-A2; U.S. patent applicationSer. No. 12/972,168, filed on Dec. 17, 2010, titled “SUTURE PASSINGINSTRUMENT AND METHOD,” now Publication No. US-2011-0152892-A1; U.S.patent application Ser. No. 13/062,664, filed on Apr. 19, 2011, titled“KNOTLESS SUTURE ANCHORS,” now Publication No. US-2011-0190815-A1; U.S.patent application Ser. No. 12/620,029, filed on Nov. 17, 2009, titled“METHODS OF SUTURING AND REPAIRING TISSUE USING A CONTINUOUS SUTUREPASSER DEVICE,” now Publication No. US-2010-0130990-A1; U.S. patentapplication Ser. No. 12/942,803, filed on Nov. 9, 2010, titled “DEVICES,SYSTEMS AND METHODS FOR MENISCUS REPAIR,” now Publication No.US-2011-0112556-A1; U.S. patent application Ser. No. 13/462,728, filedon May 2, 2012, titled “DEVICES, SYSTEMS AND METHODS FOR MENISCUSREPAIR,” now Publication No. US-2012-0265221-A1; U.S. patent applicationSer. No. 13/114,983, filed on May 24, 2011, titled “SUTURING ANDREPAIRING TISSUE USING IN VIVO SUTURE LOADING,” now Publication No.US-2011-0270280-A1; U.S. patent application Ser. No. 13/347,184, filedon Jan. 10, 2012, titled “IMPLANT AND METHOD FOR REPAIR OF THE ANTERIORCRUCIATE LIGAMENT,” now Publication No. US-2012-0179254-A1; U.S. patentapplication Ser. No. 13/247,892, filed on Sep. 28, 2011, titled“MENISCUS REPAIR,” now Publication No. US-2012-0283750-A1; U.S. patentapplication Ser. No. 13/323,391, filed on Dec. 12, 2011, titled “SUTUREPASSER DEVICES AND METHODS,” now Publication No. US-2012-0283753-A1; andU.S. patent application Ser. No. 13/462,773, filed on May 2, 2012,titled “SUTURE PASSER DEVICES AND METHODS,” now Publication No.US-2012-0283754-A1, each of which is incorporated by reference in itsentirety.

Many of the pre-tied knot variations described herein were developed foruse with one or more of these suture passer devices, and thus may beparticularly well adapted for use with these systems. However, thepre-tied knot methods and systems described herein may also be used withother suture passers, or even without suture passers, in order to secureone or more sutures.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The present invention relates to suturing techniques, devices andmethods, including pre-tied knots for surgical use and methods offorming these knots as well as sutures, suture passers, and otherdevices including or for forming surgical knots. More particularly,described herein are pre-tied suturing knots and methods of using themminimally invasively (e.g., endoscopically). Also described herein aresuture methods that use a pre-tied knot (or other fastener) attached tothe suture to aid in passing the suture, as well as suture passersadapted for use with suture that has a knot, fastener or otherenlarged-diameter region so that the enlarged region (e.g., knot) may bepassed through tissue. Finally, described herein are accessory devices,methods, and kits for tying knots in sutures.

BACKGROUND

Suturing of tissue during surgical procedures is time consuming and canbe particularly challenging in difficult to access body regions andregions that have limited clearance, such as regions partiallysurrounded or covered by bone. For many surgical procedures, it isnecessary to make a large opening in the human body to expose the arearequiring surgical repair. However, in many cases, accessing the tissuein this manner is undesirable, increasing recovery time, and exposingthe patient to greater risk of infection.

Suturing instruments (“suture passers” or “suturing devices”) have beendeveloped to assist in accessing and treating internal body regions, andto generally assist a physician in repairing tissue. Although many suchdevices are available for endoscopic and/or percutaneous use, thesedevices suffer from a variety of problems, including limited ability tonavigate and be operated within the tight confines of the body, risk ofinjury to adjacent structures, problems controlling the position and/orcondition of the tissue before, during, and after passing the suture, aswell as problems with the reliable functioning of the suture passer.

For example, some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. In addition, many of the instruments are limited by theway they grasp tissue, apply a suture, or recapture the needle andsuture. Furthermore, many of the instruments are complicated andexpensive to use due to the numerous parts and/or subassemblies requiredto make them function properly. Suturing remains a delicate andtime-consuming aspect of most surgeries, including those performedendoscopically.

During or after performance of a surgical procedure, tissues must bestitched or sutured to allow or encourage healing. Suturing, that is,the tying a tissue with a suture (e.g., thread), is well-known in theart. Moreover, pre-tied sutures and methods of suturing for externalsurgical use likewise are known, such as is described in U.S. Pat. No.3,580,256 to Wilkinson et al. The Wilkinson patent describes a pre-tiedsuture that is encased in a see-through material, taking the form of athin, flat wafer. In use, the surgeon stitches the tissue together andthen directs the needle through the loops in the wafer and draws ittight in order to make the knot. Clearly, such a convention could not beused for endoscopic and other internal surgical techniques.

In contrast, minimally invasive surgery, such as endoscopic surgery, isperformed within the interior of a body, including a body cavity orhollow organ, with the help of an endoscope or similar device tovisualize the interior portions of the body where the surgery is to beperformed. Small, low-profile or compact devices, such as suturepassers, may be used to pass a suture through the tissue, andsubsequently tie off the suture. The surgeon may observe the surgicalprocedure through a visual device whose output is displayed on a videomonitor.

In order to perform the suturing within patient's body, a suture passerwith a tissue penetrator (e.g., needle) element may pass through thetissue one or more times (including through a tissue and a non-tissuematerial, such as an implant, graft, etc.). The tissue penetrator maypass a suture directly, or it may pass an element that can later pull asuture through the tissue. A problem may arise in manipulating thetissue penetrator (e.g., needle) for easily tying a knot for closing thesurgical incision in situ. It is challenging to tie off or otherwisesecure the free end or ends of a suture, particularly minimallyinvasively. Thus, it is to be appreciated that a pre-tied suture,employable with a suture passer or grasping instrument, could greatlyfacilitate minimally invasive and other surgical procedures (evenincluding open procedures). The present invention is directed to suchmethods and systems for knotting suture that allow a pre-tied knot to bepresent, pre-attached or pre-tied onto the suture before performing thesurgical procedure.

It is also desirable to suture tissue using a suture passer that canreliably transfer a suture through the tissue without dropping thesuture. Described herein are suture passers and methods of passingsutures that enhance reliability by passing a suture that is pre-knottedor otherwise includes an enlarged region on the suture (e.g., near theend region of a suture) to reliably pass the suture (including the knot)through the tissue.

Presently, sutures that are tied to maintain a wound in a closedposition are hand-tied by the surgeon performing the procedure. Formingthe suture knot and tying off the suture knot such that the knot doesnot slip or is too slack with respect to the tissue opening can be achallenging final step in what may already be a challenging and arduousprocedure. In some instances, there is limited space and clearance for asurgeon to make the necessary movements of the tool or of their hand inthe area that is being sutured, such as areas near bone. In thoseinstances, tying a steadfast suture against the tissue to be heldtogether may be challenging. Finally, while an operating room istechnically sterile, it would still be advantageous to lessen the timean area being operated on is left open to potential infectious agents.Thus, decreasing the time it takes to tie off a suture is desirable.

While suture-related instruments such as suture passers and knot pushershave been developed to aid in reducing suturing time and suturingdifficult to access areas of the body, these devices still fall short ofbeing able to quickly tie adequate suture knots. For example, suturepushers may be able to stitch tissue even in hard to reach areas, butonce a suture requires tying off, it is still a challenge for a surgeonto easily loop the suture ends together using a suture pusher.

Surgical staples are an alternative to sutures for quickly closing awound. Unfortunately, surgical staples leave unpleasing closure marksupon healing. Thus, it would be desirable to have a device for providingan easy way to tie off a suture where there is no steep learning curvefor using such a device.

SUMMARY OF THE DISCLOSURE

The present invention relates to pre-tied knots. In particular,described herein are pre-tied knots that maybe used percutaneously witha suture passer. The pre-tied knots may include a knot body and a leadersnare. The suture with a pre-tied knot may (prior to being knotted tothe other end or a different suture) be passed through the tissue. Thus,the pre-tied knots described herein are particularly helpful for usewith suture passers that may be used minimally invasively (e.g.percutaneously). Also described are methods of knotting a suture usingthe pre-tied knots described herein, including in particular, methods ofpercutaneously repairing a torn meniscus using these pre-tied knots.

In general, described herein are sutures including pre-tied knots. Thepre-tied knot may include a knot body that is secured to, and may beformed of, the suture. The pre-tied knot may also include a leader snarethat is tied to the suture by the knot body. The leader snare typicallyincludes a first end with a loop region (e.g., a bight) that can bethreaded to hold an end of the suture, and a second end which is a tailor pull tail that can be pulled on to pull the leader snare out of theknot body. When an end of the suture is threaded into the loop/bightregion, pulling the tail of the leader snare results in closing the loopof suture at the knot body. The loop can then be cinched and/or the knotbody tightened to securely knot the loop.

For example a suture may have a pre-tied knot including: an elongateflexible length of suture (formed of suture material) having a first endand a second end; a knot body formed from the suture material at aregion near the first end of the suture, the knot body having one ormore loops of the suture material, wherein each loop has at least onecrossing point; and a leader snare formed of a length of linear andflexible material that is distinct from the suture material forming theknot body, the leader snare passing through the one or more loops of theknot body, wherein the leader snare comprises a loop or bight extendingfrom a first end of the knot body and a pull end extending from a secondend of the knot body, wherein the knot body and leader snare aresufficiently flexible and narrow of profile to be pulled through atissue behind a tissue penetrator. The tissue penetrator may be any ofthe tissue penetrators incorporated by reference above as part of asuture passer, or it may be a simple needle (including curved needles).

The knot body may have one, two, three, four, five or more loops ofsuture material. In some variations, the knot body includes three ormore loops of suture material.

The leader snare may be formed of a second piece of suture material. Theloop or bight of the leader snare may extend towards the second end ofthe suture and the pull end of the leader snare may extend towards thefirst end of the suture. In some variations, the material forming theleader snare has a larger diameter than the suture.

In some variations, the knot body is configured to slide along thelength of the suture. In other variations the knot body is relativelyfixed along the length of the suture.

Although the examples provided above include knot bodies formed of thesuture (e.g., of the length of suture), in some variations the knot bodyis a separate length of material (e.g., suture material) that is tied tothe length of suture. Alternatively, the knot body may be formed of asome other material (non-suture material) including polymeric materials,metals, alloys, ceramics, etc.

The pre-tied knot may be positioned at any position along the length ofthe elongate suture. In some variations the pre-tied knot body islocated at the proximal or distal ends. In some variations the pre-tiedknot is locate near the middle region of the suture. In some variations,the pre-tied knot is located proximal to the distal end of the device.As mentioned above, in some variations, the pre-tied knot body may beformed of a region of the elongate length of suture.

Any of the sutures having pre-tied knots described herein may be used tosuture tissue, and in particular to knot a loop of suture through and/oraround tissue. For example, described herein are methods ofpercutaneously tying a loop of suture around tissue using a pre-tiedknot, wherein the suture has a proximal end, a distal end, and apre-tied knot formed between the proximal and distal ends, wherein thepre-tied knot is tied around a leader snare so that a loop of the leadersnare extends from the pre-tied knot in a first direction and a tail ofthe leader snare extends from the pre-tied knot in a second direction,the method comprising: percutaneously passing the distal end of thesuture through the tissue; percutaneously passing the leader snarethrough the tissue; passing the distal end of the suture through theloop of the leader snare; forming a loop of suture by pulling the tailof the leader snare to draw the suture through the pre-tied knot whileremoving the leader snare from the pre-tied knot; and cinching the loopof suture around the tissue.

As mentioned, in some variation the methods may be used to knot a loopof suture using a suture passer. For example, percutaneously passing thedistal end of the suture comprises using a suture passer to pass thedistal end of the suture. Percutaneously passing the leader snare maycomprise using the suture passer to pass the leader snare.Percutaneously passing the leader snare may comprise percutaneouslypassing the loop of the leader snare through the tissue.

Any of these methods may also be used to form a loop of suture around atorn meniscus. For example, percutaneously passing the distal end of thesuture may comprise percutaneously passing the distal end of the suturefrom the inferior to the superior side of a meniscus.

Cinching may comprise pulling the distal end of the suture, which mayreduce the size of the loop. Cinching may also or alternatively comprisetightening the pre-tied knot over the suture. For example, the knot bodymay be tightened by pulling an end of the length of material forming theknot body to reduce the size (e.g., diameter) of any loops forming theknot body. As mentioned, in some variations, the knot body of thepre-tied knot is formed from the suture; in some variations the knotbody is formed of a separate length of suture or other material.

In one variation, a method of percutaneously forming a loop of suturearound a tear in a meniscus using a pre-tied knot, wherein the suturehas a proximal end, a distal end, and a pre-tied knot formed between theproximal and distal ends, and wherein the pre-tied knot is tied around aleader snare so that a loop of the leader snare extends from thepre-tied knot in a first direction and a tail of the leader snareextends from the pre-tied knot in a second direction, may include thesteps of: percutaneously passing the distal end of the suture from aninferior surface to a superior surface of the meniscus; percutaneouslypassing the leader snare from the inferior surface to the superiorsurface of the meniscus; passing the distal end of the suture throughthe loop of the leader snare; forming a loop of suture by pulling thetail of the leader snare to draw the distal end of the suture from thesuperior surface to the inferior surface and through the pre-tied knotwhile removing the leader snare from the pre-tied knot; and cinching theloop of suture around the meniscus.

In some variations, a method of percutaneously forming a loop of suturearound a tear in a meniscus using a pre-tied knot, wherein the suturehas a proximal end, a distal end, and a pre-tied knot formed between theproximal and distal ends, wherein the pre-tied knot is tied around aleader snare so that a loop of the leader snare extends from thepre-tied knot in a first direction and a tail of the leader snareextends from the pre-tied knot in a second direction, includes:percutaneously passing the distal end of the suture from a superiorsurface to an inferior surface of the meniscus; percutaneously passingthe leader snare from the superior surface to the inferior surface ofthe meniscus; passing the distal end of the suture through the loop ofthe leader snare; forming a loop of suture by pulling the tail of theleader snare to draw the distal end of the suture from the inferiorsurface to the superior surface and through the pre-tied knot whileremoving the leader snare from the pre-tied knot; and cinching the loopof suture around the meniscus.

Also described herein are methods of using a suture having a pre-tiedsuture knot. For example, described herein are methods of suturingtissue using a length of suture with a pre-tied knot, these methodsincluding the steps of: passing a suture through a tissue, wherein thesuture comprises a knot body at a region of a first end of the suture,the knot body having one or more loops of the suture around a leadersnare, wherein each loop has at least one crossing point, and furtherwherein the leader snare comprises a loop or bight formed of a length oflinear and flexible material extending from a first end of the knot bodyand a pull end extending from a second end of the knot body; passing asecond end of the suture through the loop or bight of the leader snare;pulling the pull end of the leader snare to draw the second end of thesuture through the knot body and removing the leader snare from the knotbody; and tightening the knot body around the second end of the sutureand knotting the suture.

The step of passing the suture through the tissue may further comprisespassing the knot body through the tissue. As mentioned, the pre-tiedknot may be sufficiently flexible and narrow diameter to pass throughthe tissue behind a tissue penetrator.

In some variations, the method also includes the step of sliding theknot body along the suture.

In some variations, the knot body may be tightened by pulling the firstand second ends of the suture. Once the knot is tightened, the free endsof the suture may be cut and removed.

The step of passing the suture through the tissue may include passingthe suture endoscopically using a suture passer. As mentioned above, inparticular, the methods described herein may be used to repair a tornmeniscus of the knee. Thus, the method may include passing the suturethrough the meniscus tissue. In some variations, passing the suturecomprises passing the second end of the suture through a first region ofthe tissue and passing the first end of the suture and the knot bodythrough a second region of the tissue.

In some variations, described herein are method of passing a suturethrough tissue using a tissue passers in which the portion of the suturepassed by the tissue passer includes a knot (or other enlarged region)that is driven through the tissue. Although it is counterintuitive topass a knotted portion of a suture through the tissue during repair ofthe tissue, the inventors have found this method to be surprisinglyeffective. Also described herein are suture passers that may be used ineven the most constricted anatomical regions for minimally invasively(e.g., arthroscopically) passing a suture including a knotted regionthrough the tissue. In some variations the devices and methods may beadapted to pass multiple lengths of suture (having multiple knots orenlarged regions on the suture) through the tissue using the same devicewithout having to remove the device from the tissue to reload betweenpasses.

Also described herein are devices, methods and kits for forming a simpleor complex suture knot at a first and a second end of a piece of suture.The devices and methods disclosed herein are able to quickly and easilyform a non-slipping knot that can be positioned close to the tissuesections to be closed. While it is contemplated that the knot tyingaccessories will be reusable, it is also contemplated that sterile kitsbe provide the have guide threads pre-threaded through the knot tyingdevice ready for immediate use when needed.

The devices and methods described herein are for quickly tying off twofree ends of a suture. The devices of the present invention comprise aguide body having internal pathways, a guide thread that is able tothread the guide body. The guide body can be opened and closed. In oneexample, the guide body includes openings disposed on the guide bodywhere the sections of the guide thread is exposed at these openings. Theguide body has a top and a bottom side that fit together when closed.The guide body may be opened to expose an interior space comprising aseries of pathways that are disposed on the top and bottom side of theguide body. The series of pathways may be only on one side of the guidebody or a complete pathway may be formed when the top and bottom sidesare fitted together. In other instances, the pathways on the top andbottom are different and aid in forming different portions of the sutureknot. The interior space including a convoluted pathway that crossesover itself at more than one location within the guide body. Theconvoluted pathway in some examples are essentially planar and a pieceof guide thread can be wound in a particular pattern through theconvoluted pathway.

The convoluted pathway with in the internal space of the guide body mayinclude a series of channels in which the guide thread can be placed. Inother examples, the convoluted pathway is delineated with posts or aseries of protruding bodies that allow for the guide body to be woundpast some or all of the posts or protruding bodies. There may be morethan one path through the convoluted pathway that the guide thread cantake when placed within the convoluted pathway. In some instances, theconvoluted pathway may be defined by a combination of channels andprotruding bodies. Whether the convoluted pathway is a series ofchannels, protruding bodies, or a combination of both, the path that theguide thread take within the guiding bodies generally take on softcurves able to easily slight within a channel or past the protrudingbodies.

In an exemplary embodiment, the guide thread has a capture loop on oneend while the other end is free. The length of the guide thread is suchthat there is not an excess of thread length once the guide thread hasbeen laced through the desired channels or past the series of protrudingbodies. Once properly placed within the guide body, the end of the guidethread having the capture loop extends from the guide body at a firstlocation. A bight of guide thread is exposed at a second location withregard to the guide body, and the free end of the guide thread trailsout of and away from the guide body at a third location.

The capture loop of the guide thread functions to securely hold a pieceof suture so that the corresponding length of suture may be pulledthrough the entire length of the convoluted pathway without breakingfree. The capture loop may also be a sliding knot that is able to cinchdown and hold onto a piece of suture. In some examples, the capture isconstructed from the same length of thread as the guide thread and ismade from the same material. In other examples, the capture loop can beconstructed from a material different than that of the guide thread. Insome instances, the capture loop may be constructed from a metallicmaterial. The capture loop may have a collapsible state for coupling andholding onto a suture end, and the capture loop may have an open statewhere the suture end is initially thread through the capture loop andwhen the suture is ready to be released after being threaded through theconvoluted pathway of the guide body.

The knot tying device may also include pull tabs. The pull tabs arereleasably coupled to the guide thread at locations where the guidethread is exposed with regards to the guide body. The pull tabs, whenpulled in the proper sequence, aid a user in pulling the guide threadand the appropriate suture end through the convoluted pathway of theguide body such that the suture ends replace the guide thread within theconvoluted pathway of the guide body.

The knot tying devices disclosed herein also have other forms that areable to maintain the guide thread in a particular pattern. In some otherexamples, the free suture ends may be directly threaded into the knottying device, where the suture end may be wound around the device in apattern for forming a knot. Some of the knot tying devices describedbelow may be used in conjunction with existing suturing devices such asuture passer or a suture knot pusher.

In some examples of the knot tying device shown, no actual accessorydevice is provided for. In these embodiments, the suture itself has aunique element. For example, the suture may have a pre-formed knotbundle where the pre-formed knot bundle is maintained within a suturingdevice such as a suture passer or a suture pusher.

Also described herein are methods for using the various embodiments ofthe knot tying devices described. In some instances, instructions may beincluded with any of the knot tying devices included to aid the user inusing the device. In other instances, there may be markings on theactual device for instructing the user on how to thread the guide threadwithin the convoluted pathway of the guide body and the order for pullthe pull tabs that lead to replacing the guide thread with the sutureends.

Finally, also described herein are kits that may be provided for eithera single use or multiple uses. The advantage of having a single usedevice is that the device will be maintained within a sterileenvironment until needed. Also, the surgeon performing the suturing willbe ensured that he will have all the elements of the knot tyingaccessory at his disposal when the time comes for tying off a suture.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D show variations of pre-tied suture knots (FIGS. 1C and 1D)including a leader snare (FIG. 1A) that passes through one or more loopsof a knot body (FIGS. 1B, 1C and 1D).

FIGS. 2A and 2B show two variations of leader snares similar to thatshown in FIG. 1A.

FIG. 2C shows another variation of a length of suture including apre-tied knot formed of a leader snare similar to the one shown in FIG.1A.

FIG. 2D shows another example of a length of suture including a pre-tiedknot, where the pre-tied knot includes a leader snare similar to the oneshown in FIG. 2A.

FIG. 2E shows another variation of a length of suture having a per-tiedknot, wherein the pre-tied knot is located more towards the medialregion of the length of suture than the distal or proximal end regionsof the length of suture. Note that the direction of the bight region (tothe left, or proximal end) and the direction of the tail of the leadersnare may be reversed in any of the variations described herein.

FIGS. 3A-3G illustrate one variation of a method for suturing tissue andknotting the suture with a pre-tied knot such as the pre-tied knot shownin FIG. 1C. In this example the tissue is a torn meniscus that is beingrepaired endoscopically to form a vertical loop repair, extendingthrough the meniscus twice between the superior and inferior surfaces ofthe meniscus.

FIGS. 4A-4H show another variation of a method for arthroscopicallyrepairing a torn meniscus by forming a loop of suture around the tear.

FIGS. 5A-5K illustrate another variation of a pre-tied knot. FIGS. 5Band 5K show the pre-tied knot used with a suture anchor.

FIGS. 6A-6I illustrates another variation of a method for suturingtissue in which the pre-tied knot region is configured as a suture trapincluding a leader snare.

FIG. 6J shows another variation of a suture trap and leader snare forforming pre-tied knot with a suture.

FIGS. 7A-7C show one variation of a suture passer.

FIGS. 8A, 8B, and 8D show top and two side perspective views,respectively of the distal end of the suture passer shown in FIG. 7A.

FIG. 8C illustrates the arrangement of the tissue penetrator and suturestripper in the distal end region of the suture passer of FIG. 7A.

FIGS. 9A-9C show a suture stripper including a stripper plate (FIG. 9B)and base (FIG. 9C).

FIGS. 10A and 10B show side perspective views of the distal end regionof a jaw member including a suture stripper.

FIGS. 11A-11G and 12A illustrate one method of suturing a tissue in aloop using a suture passer such as the suture passer shown in FIG. 7A.

FIGS. 12B and 12C illustrate suturing complex meniscal tears, includingthose having a radial tear, using a suture passer such as the one shownin FIG. 7A.

FIGS. 13A-13L show another illustrate of a method for suturing meniscaltissue similar to that shown in FIGS. 11A-11G.

FIGS. 14A-14J illustrate one method of passing a suture having knottedends as described herein.

FIGS. 15A-15F are drawings of a first embodiment of a knot tyingaccessory where a guide thread with has been placed within a convolutedpath of a guide body. The guide thread includes a capture loop at oneend. A first and a second pull tab are shown attached to the guidethread. FIG. 15B is a drawing showing the first embodiment where a firstsuture end threaded through the capture loop and where the first pulltab has started to be pulled. FIG. 15C is a drawing showing the firstembodiment where the first pull tab has completely pulled the guidethread and now the suture end has replaced a portion of the thread guidewithin the guide body. FIG. 15D is a drawing showing the firstembodiment where a second suture leg/end has been threaded through thecapture loop after the capture loop has traveled through a portion ofthe guide body and exited at the second opening on the guide body. FIG.15E is a drawing showing the first embodiment wherein the second sutureleg/end has been pulled through a latter portion of the guide body. FIG.15F is a drawing showing the first embodiment where the first and thesecond ends of the suture has been removed from the guide body and isready to be tightened against portions of tissue being sutured.

FIG. 16 is a drawing of a second embodiment of a suture with apre-formed knot bundle for securing tissue together.

FIG. 17 is a drawing of a third embodiment of a suture with a pre-formedknot bundle for securing tissue together.

FIG. 18 is a drawing of a fourth embodiment of a suture with apre-formed knot bundle for securing tissue together.

FIG. 19 is a drawing of a fifth embodiment of a suture with a pre-formedknot bundle for securing tissue together.

FIG. 20 is a drawing of a sixth embodiment having a sliding knot that isformed with a snare incorporated into a pre-formed knot bundle.

FIGS. 21A-21J are photos showing a seventh embodiment having a cartridgecontaining a suture having a snare in a loose knot configuration that isattached around a knot pusher or a suture passer.

FIG. 22 is a drawing of an eighth embodiment of the knot tying accessoryhaving a tubular-shaped device body 801 having a snare 811 wound aroundit in a knot bundle configuration.

FIG. 23 is a drawing of a ninth embodiment of the knot tying accessoryin the shape of a card deck including a series of pushpins.

FIG. 24 is a drawing of a tenth embodiment of the knot tying accessoryin the shape of a card deck and including snares and guides for creatinga knot.

FIGS. 25A and 25B are drawings of an eleventh embodiment of the knottying accessory having internal pathways disposed on an upper and alower portion of a device body for forming a knot pattern. FIG. 25Ashows the knot tying accessory in an open state while FIG. 25B shows theknot tying accessory in a closed state.

FIG. 26 is a drawing show a twelfth embodiment of the knot tyingaccessory having a snare, a first and a second insertion end, and a pulltab.

FIG. 27 is a drawing show a thirteenth embodiment of the knot tyingaccessory having a series of apertures 1307 that are connected withinterior pathways.

FIG. 28 is a drawing show a fourteenth embodiment of the knot tyingaccessory having a rotating piece and positioning aides for a windingtool to wind a suture into a correct knot pattern.

FIG. 29 is a drawing show a fifteenth embodiment of the knot tyingaccessory having a 3D geometric shape.

FIGS. 30A and 30B are drawings show a sixteenth embodiment of the knottying accessory having cam paths that a ball bearing can follow. FIG.30A shows a side view of this embodiment while FIG. 30B shows a topview.

FIGS. 31A and 31B are drawings of a variation of the sixteenthembodiment where the cam paths include a cleat or cleats.

FIG. 32 is a drawing showing a tool for easily forming a half hitch.

FIG. 33 is a drawing showing the formation of a stronger knot using twosnares.

FIG. 34 is a drawing of a knot tying accessory device that areimplantable.

FIG. 35 is a drawing of a second embodiment of an implantable knot tyingaccessory device having a sleeve and a plug.

FIGS. 36A-36D is a drawing showing another embodiment of an implantableknot tying accessory device having a rotatable clasp. FIG. 36B shows atop view where the top and bottom portions of the clasp are aligned.FIG. 36C is a top view of the accessory where the top and bottomportions of the clasp are not aligned. FIG. 36D is a cross-sectionalview of the device.

FIG. 37 is a drawing showing another embodiment of an implantable knottying accessory device having an implantable toggle.

FIG. 38 is a drawing showing another embodiment of an implantable knottying accessory device having a structure for bringing together andmaintaining tissue.

FIG. 39 is a drawing showing another concept for bringing together andmaintaining tissue is a suture with knots.

FIG. 40 is a drawing showing a variation of concept for bringingtogether and maintaining tissue is a suture with knots having a loopformed from dividing the width of the suture in two.

FIGS. 41A and 41B is a drawing showing a suture line with knots can alsobe slid through a pre-tied, sliding knot construct such as a girthhitch.

FIG. 42 is a drawing of another embodiment of the knot accessory showingan implant similar to a backpack strap.

FIG. 43 is a drawing of another embodiment of the knot accessory with atubular construction having an inner 28 is a drawing of anotherembodiment of the knot accessory showing an inner and an outer tube.

FIG. 44 a drawing of another embodiment of the knot accessory showing asuture bight through a hole in an implant.

FIG. 45 is a drawing of another embodiment of the knot accessory showinga mesh/grid material through which the suture is woven for maintainingthe suture.

FIGS. 46A-46E illustrate another example of a knot that may be used asdescribed herein.

FIGS. 47A-47D illustrate a cartridge pre-loaded with a knot as describedherein. The knot is passed as the suture end is passed, in FIG. 47B, anda second length of suture is passed through the tissue (triangularregion) in FIG. 47C.

FIGS. 48A-48C illustrates another variation of a suture knot that may beused as described herein.

FIGS. 49A-49G illustrate the operation of a suture with a pre-formedknot bundle that may be used in any of the variations described herein.

FIG. 50 shows a suture having a variety of openings at one end of thesuture.

FIG. 51 sows a suture having a tapered portion where the tapered portionhas a smaller diameter than the rest of the suture.

FIG. 52 is another variation of a knot that may be used.

FIGS. 53A-53E illustrate a suture with a knot that is pre-tied around aseparate disposable suture or other cord-like element.

FIG. 54 is an example of a suture passer cartridge pre-loaded with aknot.

FIGS. 55A-55E are other examples illustrating operation of a suturepasser holding a pre-tied knot.

FIG. 56 is an example of a suture passer having a suture with a loop orshuttle region at one preloaded end (in the upper jaw).

FIGS. 57 and 58 illustrate another variation of a suture passerincluding a cinching loop that creates a path after passing the sutureusing the device, so that the knot may be formed automatically.

FIGS. 59A-59B illustrate a suture passer that includes a separateknot-forming element (suture, wire, etc.) that is passed over the endsof a suture that has been passed through the tissue, as illustrated. Inthis example the suture is passed and cinched, and all four ends may betrimmed or knotted together.

DETAILED DESCRIPTION

Described herein are sutures with pre-tied suture knots that arecompatible for use in minimally invasive surgical techniques using asuture passer. The structure of different types of pre-tied knots aredescribed herein, including variations that may result in differentknots, variations formed of the suture material themselves, andvariations formed of different material(s) that may be connected to thesuture. In addition, methods of forming, placing and tying pre-tiedknots are also described. Finally, examples of the use of a pre-tiedknot to repair, anchor and otherwise fix tissue or tissue and implants(e.g., explants, implantable medical devices, and the like) are alsoprovided herein.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

The pre-tied knots described herein may be used with any appropriatetype of suture material, including any appropriate size, length and/ordiameter of suture material. Examples of suture materials may include:surgical-grade sutures such as catgut (plain, chromic), silk,polyglycolic acid, polylactic acid, polydioxanone, nylon, polypropylene,etc.

A pre-tied knot may refer to one or more knots formed in a length ofsuture, and may generally include both the knot body as well as a leadersnare that is knotted to the length of suture by the knot body. Thepre-tied knot may be formed exclusively of suture material, or it mayinclude one or more additional materials, and/or it may modify thesuture material, or it may be formed of non-suture materials (such asmetals, alloys, etc.). The pre-tied knot (e.g., the knot body of thepre-tied knot) may be loose or taut, and may be movable along a portionof the length of a suture or it may be fixed relative to a position onthe length of suture. The knot body of the pre-tied knot may be formedof the same material as the suture on which the pre-tied knot islocated, or it may be formed of a different material. The knot body maybe fixed or moveable along the length of the suture from where it ispositioned. The knot-body may also be tightenable. In some variationsthe knot body is formed at the end of the length of suture from the endof the suture material.

Structure of a Pre-Tied Knot

In general, a pre-tied suture knot as described herein may include aknot body region and a leader snare that passes through the knot body.The knot body ties the leader snare to the length of suture. In somevariations the pre-tied knot is configured to tie together a firstlength of suture to second length of suture. The first and secondlengths of suture may be on the same suture (e.g., forming a loop ofsuture) or they may be from different sutures.

As mentioned, any appropriate suture may be used with the pre-tied knotsdescribed herein. Thus a length of suture may be formed of anyappropriate material, and particularly linear materials compatible forsurgical use. A suture may be referred to as a suture or a suturethread, suture length, suture wire, suture braid, or the like. Thesuture may be made from appropriate materials, including biologicalmaterials, such as catgut suture and silk and synthetic materials,including the polyglycolic acid, polylactic acid, and polydioxanone,nylon and polypropylene. Sutures may be coated (e.g., with antimicrobialsubstances, growth-promoting substances, or the like), and may come inany appropriate sizes or ranges of sized. For example a suture ofdiameter from less than 0.01 mm diameter to greater than 0.8 mm may beused to form the suture. The suture may be monofilament or multifilament(e.g., braided).

In some variations, the knot-body of the pre-tied suture typically mayinclude one or more loops through which the leader snare, and ultimatelyone or more ends of the suture, is positioned. The loop or loops may becinched, tighten, and/or closed around the leader snare and/or suture,as described in more detail below. The loop(s) of the knot bodytypically extends along a region of the length of the suture.

In some variations, the knot body may be configured as a suture trapthat allows one-way movement of a length of suture through the suturetrap.

In some variations the knot body is formed and/or positioned near oneend, e.g., a first end, of the suture. Although generally the knot bodymay be formed from a portion of the length of the suture, in somevariations the knot body is instead formed of a separate material thatis not part of the suture length. In some variations the knot body isformed of a different length of suture material. In other variations theknot body is not formed of suture material, for example, the knot bodymay be formed as a trap, clasp, or the like that can be cinched downonto the suture and/or that allows the suture to be pulled through inonly one direction, while preventing withdrawal (and loosening) of thesuture from the knot body.

As mentioned, the knot body may be slideable along the length of thesuture, or it may be relatively fixed along the length of the suture.

A leader snare typically includes a flexible elongate (e.g., linear)body that extend through the knot body. One end of the leader snare mayinclude a snare region, which may be a loop, hook, clasp, or the like,for holding an end of the suture, and a pull end which may be used todraw the leader snare through the knot body after a portion (e.g., theend) of the suture is coupled to the leader snare. This end of theleader snare may be referred to as a loop region or bight region.Drawing the leader snare through the knot body by pulling on the pullend of the leader snare may result in pulling the end of the suturethrough the knot body, removing the leader snare, and allowing the knotbody to form a knot with the knot body to knot the suture. Both ends ofthe suture may then be drawn to shorten the suture and knot it in thetissue, as illustrated below.

The leader snare may be formed of a separate material from the sutureand/or knot body. However, in principle, the leader snare could beformed of one end (e.g., the first end of the suture. In use, the leadersnare is configured to be pulled through the knot body after one end ofthe leader snare is coupled with a length (e.g., the second end region)of the suture. Thus, the leader snare may be held within one or moreloops of the knot body. The leader snare may be loosely held, e.g.,without tightening the loop(s) of the knot body to tightly over theleader snare. In some variations the leader snare comprises a materialthat reduces the friction between the leader snare and the suturematerial. For example, the leader snare may be coated with a “slippery”material (e.g., wax, polymeric coatings, etc.). In some variation theleader snare may have a tapered width so that it can be readily drawnout in one direction (e.g., towards the first end of the suture) bypulling on the pull end. For example the length of the leader snare bodyheld within the loop(s) of the knot body may have a larger diameter atthe proximal end (closest to the pull end) that tapers towards theopposite end (the coupling end of the leader snare, e.g., the loop end.In some variations the diameter of the leader snare may be greater thanthe diameter of the suture. For example, the leader snare may be formedof a suture material that has a larger (e.g., 1.5×, 2×, 3×, etc.)diameter than the diameter of the suture and/or the knot body. This mayallow the end of the suture that is pulled through the knot body by theleader snare to be readily slid through the knot body to tighten thesuture before knotting it.

As mentioned, the leader snare may be formed of any appropriatematerial. In some variations, the leader snare is formed of a flexiblematerial. The leader snare may be completely or partially flexible. Forexample, the leader snare may be formed of a suture material that isidentical or similar to the material forming the suture and/or knotbody. In some variations, the leader snare is relatively incompressible.For example, at least a portion of the leader snare may be formed of arelatively non-compressible material, including plastics (e.g.,polymeric materials). Preventing compression of the body region of theleader snare may help keep the knot body open even when pulling on theends of the suture to pull the suture through the tissue (e.g., pullingon the first end of the suture proximal to the knot body).

In some variations, the pre-tied knot may include a second pull-stringthat is passed through the knot body, completely or in part. Removingthis pull-string (which may be a string, wire, rod, etc.) may loosen theknot body around the leader snare, and allow it to be more readily drawnthrough the knot body, and may also allow the end of the suture pulledthrough the knot body to be more easily slid through the knot body(allowing it to be more easily tightened over the tissue).

The leader snare includes a suture coupling end which may secure aportion (e.g., the second or distal end) of the suture so that it can bepulled through the knot body. As illustrated herein, in some variationsthe leader snare includes a bight or loop region through which thesuture can be placed. Any appropriate coupling means may be used,including non-loop configurations, such as hooks, graspers (e.g.,clamps), adhesives, or the like. A bight may refer to any curved sectionand/or loop in a linear material (e.g., string, wire, rope, fiber,braid, suture, etc.).

FIGS. 1A, 2A and 2B illustrate variations of leader snares that may beused with the pre-tied knots described herein. For example, in FIG. 1A,the leader snare includes a distal loop region 111 that is formed fromthe suture material forming the leader snare 107. The loop is formed bydoubling the suture material over on itself. The end of the leader snareopposite the loop is the pull end 109, and consists of the two ends ofthe suture. In some variations (e.g., FIG. 2A) the pull end is only asingle end. For example, the loop of the leader snare may be formed bysecuring the ends of the loop together leaving a single end region. InFIG. 2B, the suture forming the leader snare has been shaped into theloop region and the suture has been wrapped around itself;alternatively, the ends of the fiber forming the leader snare may beconnected, woven or otherwise attached to each other.

FIG. 1B shows one variation of a knot body that may be used as part of apre-tied knot, as shown in FIG. 1C. In this example, the knot body 103includes three loops, where each loop includes a single crossing 117.The loops are formed from the suture material near the first end of thesuture 142. The leader snare 107 shown in FIG. 1A is positioned withinthe knot body 103 as shown in FIG. 1C, so that the leader snare loop 111extends towards the long end of the suture (the second end 141) whilethe pull end of the leader snare extends proximally towards the firstend of the suture 142.

Another variation of a pre-tied knot is shown in FIG. 1D. In thisexample, the same leader snare 107 shown in FIG. 1A is illustratedwithin a knot body 133 formed from two loops (though more could beused), each loop formed to have two crossings 131, 132.

In some variations, the pull-string described above may be passedthrough the same loop as the leader snare, or it may be passed through aseparate region of the knot body (such as the loop(s) formed between thefirst and second crossings 131, 132.

FIGS. 2C-2E illustrate other variations of sutures having pre-tiedknots. For example, in FIG. 2C, the length of suture 231 has a proximaland distal end, with the pre-tied knot body 235 formed at the proximalend region 251. A leader snare 240 similar to the leader snare of FIG.1A, is knotted to the proximal end of the suture 231 by the pre-tiedknot body 235, so that the bight region 241 of the leader snare extendsproximally from the knot body and the tail (pull tail) 245 extendsdistally.

FIG. 2D shows another example of a length of suture 261 that has apre-tied knot body near the proximal end of the length of suture. Aleader snare 263, similar to the one shown in FIG. 2A, extendsproximally and is tied to the suture by the pre-tied knot body 265. Inthis example, the leader snare has a loop formed at one end of theleader snare. In some variations the leader snare is a single (e.g.,doubled-over) length of suture material forming a loop at one end, andthe pull tail at the other end. In some variations the entire leadersnare is a loop (closed loop) of material. In FIG. 2D, the tail of theleader snare extends distally and the loop/bight region extendsproximally; however, in any of these variations this direction may bereversed, and the direction of the loop/bight may be distal while thetail is proximal.

In FIG. 2E, the pre-tied knot is located away from the proximal 282 anddistal 283 ends of the length of suture, and is positioned moremedially. In this example, the pre-tied knot body 285 ties the leadersnare 832 to the region between the proximal 282 and distal 283 ends ofthe suture. Either, or both, ends of the suture may be passed throughthe bight region of the leader snare and pulled through the pre-tiedknot body to knot the suture.

Methods of Forming, Positioning and Tying Pre-Tied Knot

As mentioned, a pre-tied knot may be formed at any region of a suture,and it may be slideable or fixed relative to the suture. The pre-tiedknot is typically formed before inserting the device into the patient.The pre-tied knot may be made manually or automatically. The loops ofthe knot body may be formed over the leader snare by sequentiallylooping a length of suture over the leader snare and twisting the loopto form one or more crossings. In some variations a loop is formed bytwisting a bight of suture from a length of suture and passing theleader snare through the loops; the knot body may be tightened slightlyover the leader snare to hold it within the knot body.

In use, a suture having a pre-tied knot positioned at one end of thesuture may be passed through tissue and an end of the suture may bepulled through the pre-tied knot by passing the end of the suturethrough the leader snare and pulling the tail or pull end of the leadersnare to pull the entire leader snare though the knot body. The knot maybe tightened. In some variations, the knot is tightened after pullingthe end of the suture through the knot body by pulling one or both endsof the suture to tighten the loop. The knot body may also oralternatively be tightened down on the length of suture to complete theknot. Any loose ends of the suture can then be cut. This entireprocedure may be performed minimally invasively (e.g., through a cannulaand/or using an endoscope).

For example, FIGS. 3A-3G illustrate one variation of a method forrepairing tissue and placing a pre-tied knot in a suture. In thisexample, the tissue being repaired is the knee meniscus, and the repairmay be performed minimally invasively using a suture passer to pass thesuture through the tissue, including positioning the pre-tied knot andusing the pre-tied knot to secure the suture. Although many of theexamples described herein are shown with respect to meniscus, thesemethods and apparatuses may be used to suture any appropriate tissue,and are not limited to meniscus.

In FIG. 3A, a schematic view of a portion of a torn meniscus (shown inpartial cross-section on the left) is shown. A suture including apre-tied knot (including a leader snare, referred to as a “suture bight”in this example) is passed through the meniscus and around the tear. InFIG. 3B, the distal end of the suture is first passed through the moreapical region of the meniscus from the superior to the inferior side ofthe meniscus, to the apical side of the tear. Thereafter, the proximalend of the suture is passed from the superior to the inferior side ofthe meniscus on the opposite side of the tear, as shown in FIG. 3C. InFIG. 3D, the proximal end of the suture, including the pre-tied knot, isthen drawn through the meniscus tissue.

As discussed briefly above, the pre-tied knots described herein in somevariations are sufficiently flexible and low-profile that they may bepassed through the tissue without substantially damaging the tissue. InFIG. 3D, the pre-tied knot (including the knot body and the leadersnare) is pulled through the tissue by the suture passer, which mayinclude a tissue penetrator that can pull the suture through the tissue.Once in position, the distal end of the suture may be passed through thelarge loop of the leader snare, as shown in FIG. 3D. The pull end of theleader snare may then be drawn proximally, as shown in FIG. 3E, whichresults in the distal end of the suture passing through the knot body ofthe pre-tied knot. In FIG. 3F the pre-tied knot is moved towards thetissue by pulling the distal end of the suture, constricting the sutureloop formed after pulling the distal end through the knot body aroundthe tissue. Once the tissue is secured, the knot body may be tightenedaround the suture to tighten the knot, for example by pulling theproximal end of the suture. As shown in FIG. 3G, the ends of the suturemay then be cut, leaving the tissue sutured.

FIGS. 4A-4H illustrate another variation of a method for repairing(arthroscopically) a torn meniscus by forming a loop of suture aroundthe tear. In this example a suture passer (as described in more detailbelow) may be used to pass the suture through the meniscus of the kneeduring an arthroscopic procedure. FIG. 4A illustrates the length ofsuture having a pre-tied knot (similar to that shown in FIG. 2C) thatmay be used to repair the torn meniscus 451. As shown in FIG. 4B, thedistal end of the suture 455 may be initially passed through themeniscus (e.g., from the inferior side of the meniscus to the superiorside 460 of the meniscus) on one side of the tear, as shown. In thisexample, the distal end of the suture may exit the knee region, so thatthe distal end of the suture extends from an opening in the knee (or outof a cannula, if one is used). The loop region (bight region) of theleader snare may be loaded in to the suture passer (not shown) andpassed through the meniscus on the opposite side of the tear, as shownin FIG. 4C. In this example, the bight region is passed from theinferior to the superior surfaces of the meniscus. All or a portion ofthe bight region may also extend out of the knee (e.g., out of theaccess opening made into the knee) or it may remain within the tissue.Similarly, a portion of the suture, including the knot body and/or thetail of the leader snare, may extend from the knee so that it can beeasily manipulated. Alternatively, it may be within the tissue andmanipulated using one or more arthroscopic tools.

The distal end of the suture 455 may then be passed through the loop ofthe bight region 458, as shown in FIG. 4D, and thereafter the tail ofthe leader snare may then be pulled (proximally in this example, asshown by arrow 466) to draw the bight region and the captured distal endof the suture back through the meniscus in the same path already takenby the bight region of the leader snare, as shown in FIG. 4E. Finally,in FIG. 4F, the entire snare leader has been removed, pulling the distalend of the suture through the pre-tied knot body. The distal end of thesuture 455 then extends proximally from the knot body in this example.The knot loop formed my then be cinched around the meniscus as shown inFIGS. 4G and 4H. In this example, the loop is cinched by pulling either(or both) puling on the distal end of the suture 455 and/or pushing onthe knot body 467. Once cinched, the pre-tied knot body may also betightened. For example, one end 469 of the pre-tied knot body may bepulled to tighten the pre-tied knot body. The loose ends of the suturemay be cut off, to leave the knot body on the inferior surface of themeniscus, with the loop of suture extending from the superior to theinferior surfaces and back, surrounding the torn region.

Another example of a pre-tied suture is shown in FIG. 5A. In thisexample a pre-tied sliding knot is positioned around a pull string 503so that the opposite end of the suture can be easily pulled through thepre-tied knot. One or both suture strands of the suture can be passedthrough or around tissue. As mentioned above, the pre-tied knot and pullstring can together travel through the tunnel made by the tissuepenetrator.

In some variations, the pre-tied knot is used with an anchor, as shownin FIG. 5B. In this example a suture anchor includes a length of sutureextending from it, and a pre-tied knot is positioned at the proximal endof one length of suture, as shown.

FIG. 5C illustrates one method of using a pre-tied knot to securetissue. In this example, a suture including a pre-tied knot at one endhas been passed through a region of tissue (around a tear in thetissue). As shown in FIGS. 5D-5E, the end of the suture opposite fromthe pre-tied knot may be drawn through the loop of the leader snare. InFIG. 5F, the pull end of the leader snare may then be pulled (arrow) todraw the end of the suture through the knot body, as shown, until thesuture has been completely pulled through the knot body, and the leadersnare removed from the suture, as shown in FIG. 5G. In FIG. 5H, thearrows indicate that the suture may be cinched down onto the tissue bypulling on the end of the suture that has been pulled through the knotbody, as shown in FIG. 5I, resulting in jointing the torn tissue. Thetissue may be secured with whatever tightness is desired. The knot maybe tightened by pulling on the opposite end of the suture as mentioned,above, and the loose suture ends may be cut off. This entire proceduremay be performed percutaneously.

FIG. 5K shows a similar variation in which the suture is connected to ananchor that has been secured to the bone.

The examples shown above include pre-tied knots formed by looping aportion of a length of suture around itself one or more times to formthe knot body which can be tightened over a leader snare and then usedto secure a second region or length of suture through the knot body bycinching the knot body. In some variations the knot body forming apre-tied knot is not formed (or not just formed) of a loop of suturelength, but includes a suture trap region which permits only one-waymovement of a length of suture through the knot body (e.g., suturetrap).

FIG. 6A illustrates one variation in which a knot body is formed of asuture trap that allows one-way passing (sliding) of a suture length. Inthis example, the suture trap 601 is coupled to the suture length and aleader snare 603 (which may also be referred to as a loading eyelet).The suture trap may be formed into the body of the suture, or it may besecured over or in the suture material. For example, the suture materialmay include a central lumen that may be opened at least partially toform a one-way channel for passage of a leader snare and/or suturelength.

A one-way channel for a length of suture may be formed by includingangled fibers, filaments, barbs, etc. within the channel that engage asuture to prevent its motion only when the suture is passing in a seconddirection; as the suture passes in a first direction the suture. Forexample, the suture trap may include internal barbs, cleats, rubber,braid, or other interference fit modifications that engage with a suturein a first direction, so that when suture is within, it cannot easilycome out.

As illustrated above, a suture trap does not necessarily have to be aone-way channel for a suture length, but may be a constrictable channelthat prevents withdrawal of a suture within the channel when undertension, but not when relaxed, similar to a woven finger-trap orfinger-puzzle design. For example, a suture trap may be a modifiedsection of a suture that acts as a ‘finger trap’ that constricts over alength of suture when under tension. The example shown above in FIGS.3A-5K show variations such as this, in which the knot body is at leastpartially constricted around the leader snare.

As mentioned above a leader snare may be formed of a fine nitinol wirewith a loop on the end or any string material.

In FIG. 6A, the suture 600 includes a suture trap 601 connected to thesuture. The suture body forms an enlarged region on the length of thesuture, and a leader snare 603 passes through the suture trap. In somevariations, the suture trap is formed from the suture length. Forexample, the suture length may be a woven material, and the suture trap(e.g., knot body) may be a passage into the woven body of the suture,along a length of a lumen within the woven body, and back out of thewoven body. Once the suture has been passed through the tissue, asalready shown in FIG. 6A, a second length of suture, in this case anopposite end of the suture passing through the tissue, may be passedthrough the eyelet of the leader snare, as shown in FIG. 6B. In FIG. 6C,the leader snare is then drawn through the knot body (suture trap),drawing the length of suture that has been passed through the eyelet ofthe leader snare. This length of suture material is thus left passingthrough the knot body, as shown in FIG. 6D.

As mentioned above, in some variations the suture trap variation of aknot body is configured to permit only sliding of the suture in a singledirection (e.g., the direction of the arrow in FIG. 6C), so that theleader snare and the opposite suture length may be pulled to tighten orconstrict the suture on the tissue, while preventing loosening of theloop formed by the suture. Thus, a suture strands may be secured withina suture trap in a one-way manner. For example, a suture trap may beformed as a twisting or braiding pathway within a channel through aregion of the suture (defining the knot body), or a low-profile modifiedaccessory may form the suture trap, which may be connected to the lengthof suture. Thus the knot body (suture trap) may include a pathway thatwill only allow a length of suture to be pulled into it and tightened ina one way manner. In some variations the suture trap may also includebarbs within the tunnel in the suture at the ‘suture trap’ region, arubbery material, glue or any interference fit or material could also beincluded. This may provide a knotless means of securing a suture. Insome variations, as mentioned above, the knot body region (e.g., suturetrap) may be passed through the tissue using a suture passer (e.g.,following a needle hole created by a device, instrument or needle).

For example, in FIG. 6E the suture length that just passed through thesuture trap may be pulled distally (as shown in FIG. 6F) to tighten theloop of suture around the tissue. In FIGS. 6G and 6H the distal end ofthe suture may be pulled 625, and the pre-tied knot (e.g., the suturetrap region of the knot body) 601 may be pushed using a tool such as aknot pusher 635 to slide the trap region down to the tissue surface andtighten the loop of suture. FIG. 6I shows the completed loop tied aroundthe tissue.

In any of the variations described herein, a knot pusher may be used toassist in tying or knotting the suture. In general, the knot pusher maybe used to push a pre-tied knot body down the leg or length of suture(while holding the leg or length taut); once pushed to the tissue nearwhere it is to be secured, the second length or leg of suture may bepulled to tighten the knot.

A pre-tied knot may be any appropriate length. For example, a knot bodyof a pre-tied knot may be short (e.g., a few loops of suture, asdescribed above), or it may be long. FIG. 6J shows one variation of apre-tied knot body, configured as a suture trap, that is very long, andthat has been passed through the tissue. In this example, as in FIGS.6A-6I, the exemplary tissue is shown as knee meniscus, though thesepre-tied knots may be used with any appropriate tissue. Passing theentire suture trap/knot body through the tissue in this manner mayprovide a very strong loop.

Any of the pre-tied knots described above may be pre-packaged within asuture anchor, or loadable into a suture anchor, for use in, as anon-limiting example, rotator cuff repair or labral repair in theshoulder, hip or any soft tissue that needs to be anchored to bone.

Although the description above is broken into parts and includesspecific examples of variations of pre-tied knots, any of the featuresor elements described in any particular example or section may beincorporated into any of the other embodiments.

Pre-tied knots may also be used to suture tissue in another manner asdescribed below. In particular, pre-tied knots may be used by the suturepasser to help coordinate passage of the pre-tied knot and suturethrough the tissue.

FIGS. 7A-7C illustrate one variation of a suture passer that may be usedto place a suture having a pre-tied knot, as described above. Further, asuture passer such as the suture passer shown in FIGS. 7A-7C may also beadapted to suture tissue using one or more lengths of suture thatincludes a knot, so that the knot is passed through the tissue by thesuture passer.

The suture passer of FIGS. 7A-7C has a tissue penetrator that extendsdistally from a distal opening in the upper jaw. The tissue penetratortravels in a sigmoidal path from the lower to upper jaw. In thisvariation, two lengths of a suture (including two lengths of the samesuture, e.g., two ends of the same suture) can be loaded into the lowerjaw and sequentially passed from the lower jaw, through differentregions of the tissue and retained in the upper jaw, to pass a length ofsuture through the tissue. The suture passer show in FIGS. 7A-7C is alsoconfigured so that the upper jaw member can pivot to assume a differentangle relative to the elongate body of the device, and the lower jawmember is axially extendable distally from the distal end of theelongate member to form a distal-facing mouth with the upper jaw member.The proximal handle includes a plurality of controls for controlling thepivoting of the upper jaw member, the axial sliding of the lower jawmember, and the extension/retraction of the tissue penetrator from thelower jaw member.

FIG. 7B shows the device of FIG. 7A with the outer housing of theproximal handle 3901 removed, revealing some of the connections betweenthe controls and the device. In FIG. 7B, the distal most control 3905,the proximal handle is configured as a trigger or lever that controlsthe motion of the upper jaw member (“upper jaw control”). The upper jawcontrol may be pulled to reduce the angle of the upper jaw relative tothe long axis of the elongate member 3907. In this variation the upperjaw control is pinned and allowed to drive a tendon in the elongatemember distally when compressed to drive the upper jaw down (reducingthe angle between the upper jaw and the long axis of the elongatemember). This pivoting motion may also be referred to as scissoring(scissoring motion).

A distal control 3913 is also configured as a lever or trigger, and maybe squeezed or otherwise actuated to extend and/or retract the lower jawto form a distal-facing mouth with the upper jaw, as shown in FIGS.7A-7B. In some variations the control is further configured to controldeployment of the tissue penetrator in the sigmoidal path. For example,in some variations squeezing the distal control after completelyextending the lower jaw may deploy the tissue penetrator from the lowerto the upper jaw so that the distal end of the tissue penetrator extendsout of the upper jaw. As it extends between the upper and lower jaw, thetissue penetrator may carry a first length (bight) of suture through thetissue. Upon reaching the opposite jaw member, the suture may be removedfrom the tissue penetrator and held (e.g., by a stripper) in the upperjaw. Upon release of the distal control, the tissue penetrator maywithdraw back into the lower jaw. Actuating (e.g., squeezing) the distalcontrol 3913 again may result in the extending the tissue penetrator(along with any second length of suture) back through the tissue fromthe lower jaw to the upper jaw, where the second length of suture can beretained. Alternately, in some variations, the controls (e.g., tocontrol motion of the upper and/or lower jaw) may be separate from eachother, and/or from extending/withdrawing the tissue penetrator.Additional controls may also be included in the proximal handle, includea suture loading control (e.g., switch, toggle, etc.) for loading and/ortensioning the suture within the lower jaw member.

FIGS. 8A-8D show an enlarged view of the distal end of the device ofFIGS. 7A-7C. For example, in FIGS. 8A and 8B the upper jaw 4003 is thinand slightly radiused (e.g., curved), and is hinged to the elongateshaft region of the device. The upper jaw is also connected to a control(handle, etc.) on the proximal handle by a push/pull member (tendon,wire, rod, etc.), allowing adjustment of the angle of the upper jawmember relative to the elongate member.

In FIG. 8C, the upper and lower jaw members have been removed from thedistal end of the device shown in FIG. 8B, revealing the tissuepenetrator 4007 within the lower jaw and the stripper 4009 in the upperjaw. FIG. 8D shows the distal end of the device of FIG. 8B after thetissue penetrator has been extended across the distal-facing mouth.FIGS. 10A and 10B illustrate one variation of an upper jaw region havinga suture stripper. In FIG. 10A, the suture stripper is visible from thedistal opening at the distal end of the jaw member. In this example, thestripper includes a stripper plate 4203 with a saw-toothed edge 4205.The jaw member also includes a receiver region for the stripper platehaving a sawtooth edge 4207.

FIGS. 9A-9C show greater detail on one variation of a suture stripperthat may be used. This variation is the same as the variation shown inFIGS. 10A and 10B. Although the examples provided herein show the suturestripper in the upper jaw member, in some variations a suture strippermay be present on the lower jaw member (e.g., where the tissuepenetrator is configured to pass a length of suture from the upper jawto the lower jaw). In FIG. 9A, the stripper includes a flexible plate4101 that is fixed at the proximal end (e.g. to the upper jaw member),and pressed against a receiving plate 4103 at the distal end 4105. Insome variations the receiver is not a separate receiving plate, butmerely a region of the jaw member. Either or both the suture stripperplate 4101 and the receiver 4103 may include an edge that is adapted tocatch the suture. In FIGS. 9A-9C, both the plate 4101 and receiver 4103include edges having teeth 4105 and 4107. In this example the teeth aresaw-tooth structures that are adjacent (or abutting) in the upper jawmember. The tissue penetrator may pass between the plate 4101 and thereceiver 4103 by deflecting the plate 4101; as the end of the tissuepenetrator passes the edges 4105 and 4107, a length of suture held bythe tissue penetrator may be caught by the stripper and held between theplate and receiver as the tissue penetrator is withdrawn.

In practice, a suture passer having a distally-extending tissuepenetrator (including a pre-tied knot) may be used to repair a tissuesuch as the meniscus of the knee. FIGS. 11A-11F illustrate one method ofrepairing a torn meniscus using a suture passer such as the one shownabove in FIGS. 7A-7C.

The devices and methods described herein may be used to pass a loop ofsuture and specifically, may be used to form a vertical or horizontalstitch to repair tissue. When repairing the meniscus, a vertical stitchtypically provides the strongest repair with the least amount ofdisplacement relative to horizontal stitches or other “all-inside”approaches. The devices and methods described herein may also bereferred to as “all-inside” devices and meniscal repair techniques allowthe meniscus to be sutured directly. The suture passers described hereinmay place a fully-circumferential, vertical stitch around meniscaltears. This stitch may provide uniform compression along the entireheight of the meniscus and maintain coaptation of the tear at both theinferior and superior meniscal surfaces. Further, because of the jaw andneedle configuration, the distal extending tissue penetrator does notpenetrate the capsule wall, reducing or eliminating risk to posteriorneurovascular structures. These features may allow a greater healingresponse due to complete tissue coaptation along the entire substance ofthe tear, improved clinical outcomes due to the greater healing responseand to the anatomic reduction and fixation of the meniscus tear, mayavoid scalloping or puckering of the meniscus, and may result in lessextrusion or peripheralization of the meniscus caused by over-tensioningof suture or hybrid tensioners to the capsule. These devices can also beused to treat radial, horizontal, flap, and other complex tears inaddition to longitudinal tears.

In some variations, the suture passer devices described herein can befired blindly where arthroscopy camera access is poor, as kneestructures are protected from the needle path.

Returning now to FIGS. 7A-7C, as mentioned above, the device (e.g., inFIG. 7C) has a scissoring upper jaw that is curved (radiused). Thiscurve may be configured to follow the radius of the femoral condyle. Thelower jaw in this example is straight. The lower jaw may be recessedinto the shaft, and may slide proximal-to-distal in order to slide underthe meniscus along the tibial plateau after the upper jaw is in placealong the superior surface of the meniscus. The lower jaw contains aflexible needle, which moves vertically from the lower to upper jaw.

FIGS. 11A-11F illustrate one method of using a suture passer asillustrated in FIGS. 7A-7C to repair a torn meniscus. As mentioned, theupper jaw of the suture passer may be positioned between the superiorsurface of the meniscus and the femoral condyle, as shown in FIG. 11A.The thin and slightly curved upper jaw follows the curve of the femoralcondyle. The lower jaw is retracted within the elongate body, and hasbeen loaded with two lengths of suture (from end regions of the samesuture).

In FIG. 11B, the lower arm is initially retracted; after the upper armis positioned adjacent to the torn region to be sutured, the lower jawis extended underneath the meniscus, as shown in FIG. 11C. The slidinglower jaw may more easily accommodate the spatial constraints of theknee than a fixed or scissoring lower jaw. As described above, the lowerjaw member in this exemplary device houses a flexible tissue penetrator(e.g., needle) that can be advanced through the meniscus to deliversuture bights from the lower jaw to the upper jaw. Once the device is inposition distal to a longitudinal tear or adjacent to a radial tear, thetissue penetrator is advanced from the lower arm to the upper arm. Thetissue penetrator pulls one end of the suture strand from the lower jawto the upper jaw, where it is retained. The tissue penetrator does notpass through the upper jaw, so the femoral condyle remains protected;instead the tissue penetrator extends from a distal opening in the upperjaw, as shown in FIG. 11D. The tissue penetrator is withdrawn into thelower jaw where it engages the opposite end of the suture strand. Thedevice is then repositioned for the second bight, either proximal of alongitudinal tear (see FIG. 11E) or to the other side of a radial tear(not shown in the example). Once in position, the tissue penetrator isadvanced to deposit the remaining suture bight in the upper jaw, asshown in FIG. 11E.

The tissue penetrator can then be brought back into the lower jaw, thelower jaw retracted, and the device may be withdrawn from the knee,leaving a suture loop surrounding the tear, as shown in FIG. 11F, withboth ends exiting on the femoral side. A surgeon may then tie andadvance a sliding knot (or individual throws) percutaneously, and theloose ends cut, as shown in FIG. 11G. Since both suture-ends may beretrieved through the same track, a cannula is not required to preventtissue bridging. This may result in a fully-circumferential, verticalstitch around the tear, as shown in FIG. 11G. This vertical stitchcompletely surrounds the meniscal tear, bringing the superior andinferior margins of the tear in apposition along with the meniscal areain between. FIG. 12A shows a perspective view of a portion of a meniscusrepaired in this manner. FIGS. 12B and 12C illustrate how the device andmethods described above may also be used to suture more complex meniscaltears, including those having a radial tear.

FIGS. 13A-13L illustrate another example of a method for suturing a tornmeniscus by passing a loop of meniscus. As just described, the exemplarydevice shown in FIGS. 13A-13C may be used or other variations of thesuture passer devices described herein may be used to suture a tornmeniscus. In this example, two regions of a suture are initially loadedinto the suture passer in the lower jaw. For example, the first lengthof suture may be loaded into the tissue penetrator and a second lengthof suture may be held in a holding region of the lower jaw; the lowerjaw may be configured so that once the first length of suture has beenpassed into the upper jaw member and the tissue penetrator has beenretracted, the second length of suture may be loaded into the tissuepenetrator for passing through the tissue. In FIG. 13A, the ends of thesuture are shown loaded into the lower jaw. In FIG. 13B and subsequentFIGS. 13C-13K, the upper jaw has been removed from the device shown inFIG. 13A to show the deflecting surface and suture stripper (a sheet ofmetal) in the upper jaw. In FIG. 13C, the tissue penetrator may then beextended from the lower jaw, carrying a length of suture, and pushedthrough the meniscus towards the upper jaw. The suture passer may thenenter into the upper jaw and be deflected by the deflector region withinthe upper jaw so that it extends distally out of the upper jaw member,as shown in FIG. 13D. In this example, as the tissue penetrator pushesup into the upper jaw it pushes the stripper out of the way, allowingthe suture to advance beyond the end of the stripper. In FIG. 13E,retracting the tissue penetrator leaves the suture held by the stripperin the upper jaw. The stripper places a downward force on the tissuepenetrator as it retracts, this force strips the suture off of thetissue penetrator and then pins the suture length in the upper jaw.

As shown in FIG. 13F, the device may then be repositioned to fire asecond time. The device is moved to the second location. Moving thedevice does not dislodge the suture from the upper jaw, as it is securedby the stripper. Retracting the tissue penetrator into the lower jaw maycause the second end of the suture to be loaded into the tissuepenetrator, as shown in FIG. 13G.

The tissue penetrator can then be extended back across the tissue fromthe second position on the opposite side of the meniscal tear, as shownin FIG. 13H. The tissue penetrator carries the second length of suturewith it to the upper jaw, and past the stripper again, as shown in FIG.13I. As before, withdrawing the tissue penetrator after extending it outof the distal end of the upper jaw so that the second length of sutureextends beyond the stripper results in the stripper retaining the secondlength of suture along with the first length of suture, as shown in FIG.13J. The device may then be retracted with both sutures pinned in theupper jaw, as shown in FIG. 13K. The device may be fully retraced, andthe ends of the suture tied, as shown in FIG. 13L. As discussed above,the suture may be tied using a pre-tied knot. Thus, one or the otherloop of suture lengths (bights) passed through the tissue as describedabove for FIGS. 13C/13D and 13H/13I may include a pre-tied knot that ispassed with the length of suture.

Alternatively, in some variations a knot of suture may be passed throughtissue using a suture passer as describe above in which a pre-tide knotis used to help secure the length of suture being passed to the device.For example, in some variations an end region of one or both (invariations in which two lengths of suture are being passed) lengths ofsuture are knotted, and this pre-tied knot may be passed through thetissue by the tissue penetrator. The pre-tied knot may or may notinclude a leader snare as described above. For example, in somevariations two lengths of suture (from the same elongate suture) may bepassed through a tissue; both lengths may be pre-knotted, however onlyone of the pre-tied knots may include a leader snare and be configuredto allow another length of suture to be pulled through.

FIGS. 14A-14J illustrate a method of passing a suture (two length ofsuture in this example, though a single pass may also be performed)using a knot capture method in which the lengths of suture are knottednear their ends and the knots of suture are passed by a suture passer.In this example a plastic piece is used to represent tissue. Althoughthese figures describe pre-knotted ends, in some variations the “knots”are formed by non-suture materials, or by means other than tying thesuture. For example, as mentioned above in the general case, a “knot”may be formed exclusively from loops of suture, or it may be formedwithout looping the suture, and/or from non-suture material. Forexample, in FIGS. 14A-14J, the knots at the ends of the suture may beformed by heating the suture ends to create an enlarged region (e.g., a“mushroom head” feature), by crimping a metal piece that helpsfacilitate suture trapping, by creating an eye splice or eyelet in theends of the suture which interact with the needle, etc. One or bothknots in the suture may be formed in this manner. In general, such knotsare formed by an enlarged region relative to the rest of the length ofthe suture.

For example, in FIG. 14A an elongate line of suture is knotted at bothends, and these ends are loaded into the suture passer. In this example,the suture passer is similar to the variation shown above (e.g., inFIGS. 7A-7C), and the suture knots are pre-loaded into the lower lawmember, which is adapted to hold them. In some variations the entireline of suture is pre-loaded into the lower jaw. The tissue penetratormay include a suture retainer comprising a hooked region into which thenarrower region of the suture (behind the knot at the end of the suture)may fit. The hook region may be smaller than the diameter of the knot.Thus, the suture end may be held securely in the hook region whilepassing the suture end through the tissue, and it may be uncoupled fromthe tissue penetrator when it is withdrawn in the opposite direction.

As mentioned above, in this example, the suture may be held within thetissue penetrator (e.g., in the body of the device) to protect it as itis being used. For example in FIG. 14B the suture extends through thelower jaw and through the elongate length of the member until it exitsnear the distal handle. Thus, the suture may be held within the body ofthe device either completely or partially. The knotted ends may bepulled taught into the lower jaw (FIG. 14C); the knotted ends may becompletely pulled into the lower jaw, as shown in FIG. 14D. Once thedevice is pre-loaded with suture, the lower jaw may be retracted; thesuture may be pulled taut proximally so that the distal knots remain inthe lower jaw, even as it is retracted axially.

The device may be similar to the device described above, but may beadapted to hold one or (as shown in this example) more (e.g., 2) knotsat the ends of the suture length.

The device may be placed over the tissue as described above (e.g., byadjusting the angle of the upper jaw, and extending/retracting the lowerjaw as necessary to surround the tissue to be sutured in thedistal-facing opening, as shown in FIG. 14E. In this example, the tissuepenetrator extends from the lower jaw, carrying a first knotted end ofthe suture through the tissue and up into the upper jaw and distally outof the upper jaw. The suture is held in the tissue penetrator 1401 andthe knot 1405 prevents it from pulling out, as illustrated in FIG. 14E.Thus, the tissue penetrator picks up on the knot and drags the sutureline (and knot) through the tissue and up into and through the upperjaw. In some variations the knot and suture may be held in the upper jawand the tissue penetrator may extend up and pull the knot down to thelower jaw, instead.

After passing the knot to the upper jaw, the knot may be retained by astrip mechanism in the upper jaw (not visible, but see, e.g., FIG. 9A),and the tissue penetrator retracted. In some variations the retainer inthe tissue penetrator (e.g., cut-out region, opening, etc.) is angled sothat withdrawing the tissue penetrator readily allows the suture to exitthe tissue penetrator, although when driving the suture through thetissue the suture remains seated in the tissue penetrator. In FIG. 14Fthe device has been withdrawn from the tissue model to illustrate thesingle pass of the suture after retraction of the tissue penetrator. Inpractice, the suture passer device may remain on the tissue, althoughthe position may be adjusted, and it does not need to be completelywithdrawn from the tissue to reload another suture end. The device maythus be repositioned on the tissue to make the second pass of thesuture, without removing the device from the body (or far from thetissue).

The tissue penetrator may be extended again across the tissue to passthe second end of the suture. The second end of the suture may beautomatically reloaded into the tissue penetrator. For example, thesecond end and knot may be held in a holding region of the lower jaw;once the tissue penetrator returns to the lower jaw and the sutureretainer in the tissue penetrator is empty, the second suture length(the second end) behind the knot may enter the suture retainer.

In FIG. 14C, the second end of the suture is passed through the modeltissue by again advancing the tissue penetrator. The second knot ispassed from the lower jaw member, through the tissue, and up and intothe upper jaw. Because the suture is knotted it is held securely by theupper jaw (e.g., the strip mechanism in the upper jaw). Knots are notable to come back through the upper jaw strip mechanism. Once both ends(or lengths) of the suture have been passed, the suture passer devicemay be removed from the tissue as shown in FIG. 14H. In FIG. 14H thedevice has been removed without retracting the lower jaw, however ingeneral, the lower jaw may be retracted and the upper jaw bent asnecessary to remove the device from within a narrow region of tissue(e.g., the knee). The suture will be left behind in the tissue and thepreloaded suture may be pulled from the lower jaw to allow the device tobe retracted fully, leaving the loop of suture passed through thetissue, as shown in FIG. 14I. This loop may be pulled taught, as shownin FIG. 14J. Finally, the ends of the suture removed from the tissuepenetrator and the loop knotted or tied.

In some variations the ends of the suture (knots) are cut from thesuture passer. In some variation, a release mechanism may release theknots from the mechanism (e.g., strip mechanism) in the upper jawholding them. For example, a release on the handle may remove tensionfrom the strip mechanism, allowing the knots to be released from theupper jaw. In some variations at least one of the knots may be apre-tied knot as described above, or an additional pre-tied knot may belocated proximally to one of the end knots. Thus, a pre-tied knot may beused to tie the two ends together to secure the loop within the tissue.

In general, a device that passes a knot through the tissue may bereferred to as a knot capture device, since it is configured to captureand pass knots that are tied to a length of suture (particular near theend or ends of the suture length).

Knot-tying Jigs

Also described herein are devices for aiding a healthcare professionalwith tying secure suture knots quickly and easily. In general, the knottying accessory includes a guide body and a plurality of guides withinor on the surface of the guide body for winding a piece of guide threador suture through. In some embodiments of the knot tying accessorydevice, the device includes capture loops disposed on the end or ends ofthe guide thread that aid in pulling the suture ends through the guidebody to form a particular knot pattern.

In general, the guide body is a first portion of the knot tyingaccessory device. The term “guide body” is used to describe portion ofthe device that is able to accept and retain the piece of guide threador the piece of guide thread coupled to a bight of suture. The guidebody can be any particular shape. In some of the examples, the guidebody is in the shape of a rectangular case. The guide body in someinstances can be opened to expose an interior space that is defined bychannels. The guide body may also include a series of openings where theguide thread is first threated and where portions of the guide thread isaccessible.

The guide body may be constructed to resemble a puzzle having openingsor couplers. In these instances, the guide thread or the bight of suturemay be coupled in a particular way about the guide body. After the guidethread or the suture has been coupled to the guide body, portions of theguide body is able to rotate in a particular sequence to form a knot. Inthe case, where the guide thread is used, the guide thread would thencouple to the end of a suture and be used to pull the suture through thepath about the guide body. Once the knot has been formed, the guide bodyis able to release the knotted suture, where the knotted suture may thenbe cinched down against the tissue.

The guide body may be constructed of any suitable materials such asplastics, metals, and other natural, manmade materials, or somecombination thereof. In some instances, there may be instructions ordirections on the guide body to aid the user in lacing the guide threador the suture in the device body. The instructions may be arrows,numbers, wording, or pictures that show how to thread the guide threador suture through the device.

In general, the term “convoluted pathway” as used in this disclosuremeans the path or paths defined within the interior space, the outersurface, or a combination of inner and outer surface that is able todefine a pathway, where the pathway may cross over itself at multiplepoints throughout the path. In some embodiments, the guide body includeschannels within its interior space that define the convoluted pathway.In other embodiments, instead of channels, posts or other protrusionsmay be included within the interior space of the guide body for lacingthe guide or suture thread through the convoluted path. Also, acombination of channels and/or protrusion may also be used. In someexamples of the channels and/or protrusions that define the pathwaysavailable for the guide or suture thread are stationary and thus able toonly define a limited number of convoluted pathways within the guidebody. In other examples, the channels and/or protrusions that define theconvoluted pathway may be adjusted to form new pathways through whichthe guide or suture thread may be laced to form new knot patterns.

Typically the convoluted pathways that the suture and guide thread willtake has a sweet spot with regards to the angles of each of the turnsthat the path would take. It would not be desirable to have the guide orsuture thread move past a sharp ninety degree angle as this would causemuch friction and may case the guide or suture thread to be caughtwithin the device body. It is thus preferable to have the pathway thatthe guide or suture thread travel be curved or straight to reduce theamount of friction when the guide or suture thread experiences whilebeing pulled through the convoluted pathway.

In general, the term “guide thread” is used to describe a line that isable to couple with a bight of suture. The guide thread is pre-lacedwithin the guide body prior to coupling with the bight of suture. Theguide thread may be constructed from a thread made of natural orsynthetic material. One criterion is that the guide thread be easilypulled within the convoluted pathway of the guide body. In someinstances, the guide thread may be coated with a material having a lowcoefficient of friction. In other instances, a lubricating substance maybe interwoven into the thread fibers. The coefficient of friction beingless than 0.5 or less than 0.1.

In some of the embodiments of the knot tying accessory device, the guidethread includes a “capture loop” at one end. In general, the captureloop functions to couple with the bight of suture and to pull the suturethrough the convoluted pathway for forming a knot. The capture look maybe of the same material as that of the rest of the guide thread or of adifferent material. In some examples, the capture loop is a piece ofthread-like material and may be cinch down onto the bight of suture likea sliding knot. In other examples, the capture loop may contain amechanism for clamping down and grabbing the bight of suture for drawingthe bight of suture through the guide body and then releasing the bightof suture once the suture has been drawn through the desired portions.

The knot tying accessory may also include “pull tabs”. In general, “pulltabs” are tabs or pulls that can couple to portions of the guide threadthat are exposed when the guide thread has been threaded within theguide body. The pull tabs can be of any suitable shape or size as longas they are easy to pull and grip. The pull tabs may be able to coupleto the bight of suture through a coupler such as a clip.

A first embodiment of the knot tying device 100 is shown in FIGS.15A-15F. Device 100 includes a device body 101; a series of openings,102, 103, 104, and 105; an interior pathway 106; a guide thread 110, anda first and a second pull tab 112 and 113, respectively. In thisembodiment, the device is largely rectangular but the device body cantake on any shape suitable for having an internal pathway that can guidea line such as a thread to be tied into a knot pattern. In someexamples, the device is openable to show the interior pathway. A usercan then thread the guide thread 110 through the interior pathway 106 toarrive at what is shown in FIG. 15A. In some instances, there may beinstructions on the device body using arrows, numbers, or other suitableinstructions to aid the user in threading the guide thread through theinterior pathway. In other instances, there may be separate instructionson how to thread the guide thread through the interior pathway. Theremay also be multiple ways that a line may be threaded through theinterior pathway for forming a knot.

FIG. 15A shows the guide thread 110 already laced through the interiorpathway 106. The interior pathway 106 will typically have a convolutedroute for forming a complex knot wherein the path forces the linefollowing its path to cross over on itself at least once and often timesmore than once. FIG. 15A also shows that the guide thread 110 alsoincludes a capture loop 111 that is disposed on an end of guide thread110. The guide thread 110 is a contiguous piece of material. The captureloop 111 in FIG. 15A is shown at opening 102. The guide thread comprisesa single piece of material. The lighter color portion of the guidethread 110 shown in FIGS. 15A-15F are for showing the portion of theguide thread 110 that will be exchanged with a first end of a suture.

FIG. 15B shows the next step where the first end of a piece of suture isinserted through capture loop 111. A user can then pull the first pulltab 112 to start the exchange of the guide thread 110 with a portion ofthe first end of the suture where the first end of the suture enters theinterior pathway 106 of the device body 101 at opening 102. Note herethat the first pull tab 112, located at opening 103, can only easilypull on one side of the guide thread 110. In the setup shown for thisembodiment, the second pull tab 113 prevents the upper or left portionof the guide thread 110 from being pulled through the interior pathway106 and only the right or lower portion of the guide thread 110 is ableto be pulled through the interior pathway 106.

FIG. 15C shows the resulting configuration once the first end of thesuture has completely replaced the first portion of the guide thread 110within the interior pathway 106. Here, the capture loop 111 end of theguide thread 110 has exited the first portion of the interior pathway106. The first pull tab 112 can be uncoupled from the guide thread 110.Next, the user can pull second pull tab 113 which is attached to asecond, free end of the guide thread 110. This brings the capture loop111 to the opening 104.

Turning to FIGS. 15D, 15E, and 15F, the capture loop 111 is shown beingcoupled to a second end of the suture in FIG. 15D. The user can pull onthe second pull tab 113 which starts the replacement of the latterportion of the guide thread 110 with the second end of the suture. Theuser will continue to pull on the second pull tab 113 until the secondend of the suture starts to exit from opening 105. At that point, theentire interior pathway 106 has been replace with the first and thesecond suture ends. Finally, FIG. 15F shows the loose knot configurationafter the user has removed the device from the knot. The knot bundlethan can be cinched against the tissue to hold the suture together.

Turning to FIG. 16, a suture having a pre-formed knot bundle 230 at afirst end is shown. The preformed knot bundle 230 may also include aloop 232 at a first end of the suture. The pre-formed knot bundle 230may be pre-loaded into a suturing device, such as a suture passer, wherethe pre-formed knot bundle 230 may be entirely contained within thesuture or reside on the outside of the suture passer. The knot bundle230 may be passed through tissue at a first location and a free end ofthe suture is passed through tissue at a second location. The free endof the suture is then able to pass through the loop 232, where the knotformed may be tightened into a final position against the tissue tocomplete the repair.

Turning to FIG. 17, a third embodiment of a knot tying device 300 isshown. In this embodiment, a pre-tied knot bundle 330 is located at afirst end of the suture. The pre-tied suture may be pre-loaded into asuture device such as a suture passer. Unlike the previous embodiment,the pre-tied knot bundle 330 is not passed through the tissue. A longloop 332 that extends from the knot bundle 330 may be passed through thetissue at a first location, and a second send of the suture is passedthrough the tissue at a second location. The second end of the suturemay then be passed through the loop 332 and the loop 332 is then used topull the second end of the suture through the tissue and into the knotbundle 330. The knot coupling the knot bundle 330 and the second end ofthe suture is then tightened into a final position to complete therepair. In other examples, the pre-tied knot bundle may include looseloops of suture that can facilitate the insertion of the second end ofthe suture (the free end of the suture) into the pre-tied knot bundle.

FIG. 18 shows a fourth embodiment of a knot tying device 400 having asuture with a pre-tied knot bundle 430 at a first end of the suture. Thepre-tied knot bundle 430 may also be pre-loaded into a suture devicesuch as a suture passer. Similar to the previous embodiment, thepre-tied knot bundle 430 is not passed through the tissue. A bight ofsuture adjacent to the pre-tied knot bundle 430 is passed through tissueat a first location and the free, second end of the suture is passedthrough tissue at a second location. The pre-tied knot bundle 430 isthen passed through the bight of suture and the bight of suture is thenused to pull the free, second end of the suture through the tissue. Thefree, second end of the suture is then passed through the pre-tied knotbundle to form a completed knot, and the completed knot can then betightened into its final position to complete the repair.

FIG. 19 shows a fifth embodiment of a knot tying device 500 having apre-tied knot bundle 530 disposed on a first end of a suture. In thisembodiment, the pre-tied knot bundle 530 is intended to be part of asuture subassembly. This suture assembly may be shuttled into the tissuewhere this is accomplished by using a first suture that has already beenpassed through tissue to shuttle the suture subassembly through tissue,exchanging the first suture for the suture subassembly. A free, secondend of the suture subassembly may then be passed through the pre-tiedknot bundle, and the suture subassembly can be shuttled through thetissue and through the pre-tied knot bundle in a single operation. Thecompleted knot is then tightened into its final position to complete therepair.

In yet another variation of some of the previous embodiments, a sutureincludes a pre-tied knot bundle disposed at a first end of the suturethat can be part of a suture subassembly. In this embodiment, the suturesubassembly may be contained within a knot pusher. The suture containedin the knot pusher is configured such that when a free, second end ofthe suture is shuttled through the tissue and back through the pre-tiedknot bundle, the suture is already conveniently loaded with thecompleted knot at the end of the knot pusher. This embodiment would notrequire the additional steps of leading the suture by hand into the knotpusher

FIG. 20 shows a sixth embodiment of a knot tying accessory 600. Thisembodiment includes a sliding knot 634 that is formed with a snare 635incorporated into a pre-formed knot bundle 630. In some examples, thecomplete knot may be provided in a pre-tied configuration or it may beformed through an accessory device. The complete knot would first slidedown a post-tissue leg of the suture. The post-tissue leg may then beinserted into a snare and pull through the knot, forming a convolutedpathway of the post-tissue leg through the knot. This configurationprovides a more secure knot that would not slide as easily as theoriginal knot.

FIGS. 21A-21I shows a seventh embodiment shows a cartridge containing asuture having a snare in a loose knot configuration that is attachedaround a knot pusher. Once the suture has been passed through tissue, afirst end of the suture is loaded into an open end of the snare in thecartridge. The snare may then be pulled to form the suture into a loosesliding knot configuration. A second end of the suture is then loadedinto the knot pusher to form a post-tissue leg of the suture. The looseknot configuration bundle is then released from the cartridge andtransferred over the post-tissue leg of the suture, where it is thenslid down into a final position and tightened to complete the repairknot.

In a variation of the previous embodiment, the knot tying accessoryincludes a cartridge containing a snare in a loose knot configurationthat is wound around a suture passer (FIG. 21H). Once the ends of asuture have passed through tissue and captured within the jaws of thesuture passer, a first end of the suture is removed from the suturepasser jaw and is then loaded into the open end of the snare in thecartridge. The snare is then pulled to form the first suture end into aloose sliding knot configuration. The loose knot configuration is thenreleased from the cartridge and transferred over the second end of thesuture that remains attached to the suture passer jaw. The complete knotis then slid down into its final position and tightened to complete therepair loop.

In yet another variation of a previous embodiment, the knot tyingaccessory includes a cartridge that is designed with components to passa preloaded suture (FIGS. 21I and 21J). Also included are components tofacilitate forming a knot into a loose sliding knot configuration, suchas a snare. The cartridge may be loaded into a suture passer handle.Both ends of the preloaded suture may be delivered through tissue andcaptured by a suture passer jaw. A first end of the suture can beremoved from the suture passer jaw and loaded into a receiving componentin the cartridge, such as an open snare. The first end of the suture isthe pulled via the components into a loose sliding knot configuration.The loose knot configuration is then released from the cartridge andtransferred over the second end of the suture remaining attached to thesuture passer jaw. By pulling back on the suture passer handle, theremaining second end of the suture is deployed from the cartridge andthe complete knot is slid down into its final position to complete therepair loop.

An eight embodiment of the knot tying device 800 (FIG. 22) includes atubular-shaped device body 801 having a snare 811 wound around it in aknot bundle configuration. After the suture is laced into place, a firstsuture end is loaded into the receiving/open part of the snare 811, andwhen the snare 811 is pulled, the first suture end is pulled into theloose sliding knot configuration. The second end of the suture isthreaded through the device body 801 and becomes a stem for the knot.Pulling the stem pulls the loose knot bundle off the device body andcreates a sliding knot on the stem. In some examples, the device body istapered, which aids in having uniform tightening of the knot bundle. Inother examples, the device body may be collapsible allowing the knot tobe easily pulled off. In yet another example, the device body includespins or other forms of protrusions that are able to separate differentportions of the snare winding elements. This layout allows for theformation of a knot through discrete phases (i.e. for a Revo knot, anunderhand hitch, followed by another underhand hitch, followed by anoverhand hitch).

A ninth embodiment of the knot tying device 900 (FIG. 23) includes adevice body 901 that is in the shape of a card deck. The device body 901includes a series of pushpins 920 each having notches 922 for forming acompleted knot. A bight of suture is placed in the appropriate notches922 of each pushpin 920 and with the aid of internal components, bypushing the pushpins 920 in a particular sequence forms a knot with thedesired configuration.

A tenth embodiment of the knot tying device 1000 is shown in FIG. 24.Here, the device body 1001 is in the shape of a card deck. Device 1000includes snare 1011 wound around guides 1106. The guides may be channels(as shown) or post/protrusions within the device body for guiding aguide thread 1010. A first suture end is snared through the device body1001. In the example where only one snare is present, the second sutureend is inserted through a channel 1107 in the device body 1001. Thecompleted knot can then be released by opening or breaking apart thecard-shaped device body 1001. In some examples, portions of the devicebody can be constructed from a foam material such that the knot can bepulled to release from the card-shaped device body. In other examples,the card-shaped device body may include two halves coupled wherein thecompleted knot may be released by unfolding the card. The two halves ofthe device body may have a hinged arrangement or may be slidinglycoupled.

Turning to FIGS. 25A and 25B, an eleventh embodiment of the knot tyingdevice 1100 is shown. In this embodiment, the device body 1101 also hasa rectangular form. No capture loop is used. The user opens the devicebody (the open device body is shown in FIG. 25A). The user then lays afirst end of the suture into the appropriate interior pathways 1106. Theinternal pathways may be channels or may be posts or other suitableelement for retaining a bight of thread. Note that the device body isdivided into an upper portion and a lower portion where the pathways ofthe upper portion is not necessarily the same as that for the lowerportion. As before, there may be instructions imprinted on the actualdevice or there may be separate instructions for how to place a guidethread within the interior pathway 1106 of device 1100. The user thencloses the device and inserts a second end of the suture the internalpathway 1106 (channels in the case), where the channels have theappropriate lead-ins to aid the second end of the suture cross underand/or over the first end of the suture. Once the second end of thesuture has exited the device 1100, the device 1100 may be opened torelease the formed knot.

A twelfth embodiment of the knot tying device 1200 is shown in FIG. 26.Device 1200 includes one single length snare 1211 having a first and asecond insertion end 1214 and 1215 and a pull tab 1212. The two legs ofsnare 1211 may form a loose knot configuration from being threadedthrough an interior pathway 1206. Snares 1214 and 1215 are able tocouple with a first and a second end of a suture and the loose knotconfiguration may be transferred to the suture when the first and thesecond of the suture are pulled through a device body 1201 using thepull tab 1212.

A thirteenth embodiment of the knot tying device 1300 is shown in FIG.27. Device 1300 also include a device body 1301 in the shape of a carddeck. Device 1300 also includes a series of apertures 1307 that areconnected with interior pathways 1306. Simple instructions may beprovided to a user for inserting the suture through the apertures 1307in a sequence that result in a desired knot formation. The device body1301 may then be open or broken apart to release a completed knot.

In a variation on the previous embodiments of the knot tying devicehaving an interior pathway, this embodiment includes a straight channelfor insertion of a post-tissue suture end and instructions for asequence of winding to form a sliding knot (e.g. a taut line hitchformed by wrapping twice around a distal portion of a tool and oncearound a proximal end of the tool). The card-shaped device body alsoincludes cleats for holding the two regions of the knot separate to aidin winding the desired pattern.

In yet another variation of the knot tying accessory device 1400, thedevice body may include a rotating piece 1430 and positioning aides 1432for a winding tool to wind a suture into a correct knot configuration(FIG. 28). In some examples, a first end of a suture is secured to acarriage. The carriage is rotated and translated on the tube to tie thesuture tail. The post-tissue second of the suture is inserted in thetube and the knot is slid off the tube onto the post.

In yet another variation of the knot tying accessory device, a 3Dgeometric shape like a Hoberman Ball to move suture ends (placed intoparts of the ball and being held by couplers 1511 when the ball is inits expanded configuration) into a knot configuration (created bycollapsing the ball inwards) FIG. 29.

In yet another variation of the knot tying accessory device, a conceptof cam paths 1606 that a ball bearing 1630 follows is shown in FIGS. 30Aand 30B. The ball bearing has a cleat or snare loop 1611 to hold onto asuture end. A cord is attached to the bearing such that when it ispulled, the ball bearing attached to the suture follows the path to tiea knot. The suture can then drop to the interior of the cylinder and theknot is released. The cam path can move radially, circumferentially, andaxially to form complex knot patterns with overlapping sections. Avariation of the previous embodiment is shown in FIGS. 30A and 30B wherecam paths with a cleat that spins along and up the cam path to wrap thesuture around the post strand. At the end, the cam springs back downwith one half spin to complete SMC knot. A possible cleat shape is shownin FIG. 30B.

Another variation of the knot tying accessory device is shown in FIGS.31A and 31B. In this variation on the embodiment directly before, thecam paths includes a cleat 1736 that spins along and up the cam path towrap the suture around the post strand. At the end, the cam springs backdown with one half spin to complete SMC knot. A possible cleat shape isshown in FIG. 31B.

Also disclosed are concepts for a tool for quickly forming half-hitchesin a suture (FIG. 32). The tool has a long body and a hook 1836 at oneend. The suture is wrapped around the shaft of the tool, and then thehook is used to pull the suture through the wrap, forming a half hitch.The shaft of the tool has a greater diameter than that of the hook.

Also disclosed herein are concepts for tying a stronger knot (FIG. 33).The concept below shows a knot pusher that forms and tightens squareknots at the repair site. The knot pusher (shown in green below) haspairs of snares at the distal end, and the suture ends would be snaredin and pulled tightly in directions perpendicular to the axis of theknot pusher to create levels of a square knot (shown in orange). A firstset of snares may be nested into a second set of snares, so that thefirst set of snares may be pulled to form the first level of the knot,then pull the suture into the second set of snares. The second set ofsnares can then be pulled to form the second level of the knot. Furthernested sets of snares may be used to form an arbitrary number of levelsof the knot to increase the knot strength. A variation of the previousconcept creates half hitches at the end of the knot pusher, which thenfacilitates tightening those half hitches. This might be accomplished bya different configuration of snares. This may also be accomplished by arotating member of the knot pusher that forms a suture line into a halfhitch pattern.

The following knot tying accessory devices are implantable devices. FIG.34 shows one example of such a device. Here, a short tube or sleeveimplant 2001 that would be crimped closed around the suture ends havinga holder 2011. One embodiment is a metal sleeve that is overmolded withplastic to soften the contact surfaces and prevent chondral tissuedamage. The sleeve could also be sized to remove twists from the suturesto increase the holding strength.

Another embodiment of an implantable knot tying accessory is shown inFIG. 35. Here, a suture that is slid through an implantable sleeve 2120,and then a plug 2122 is pressed into the sleeve to trap the suture inplace. Pressing the two portions together may be accomplished by anaccessory device. In some examples, an implantable clip that squeezesshut to hold the suture ends and close the repair loop. In otherexamples, an implantable clip that squeezes shut to hold the suture endsand close the repair loop. In yet other examples, an implantablerotating clasp holds the suture ends in place. Initially, the top andbottom pieces of the clasp are aligned so that there is a straight lumenthrough which the sutures can slide. Once the repair is appropriatelytensioned, the one of the ends of the clasp is rotated so that thesuture pathway becomes tortuous and small, thus holding the suture inplace. In other examples, the implantable accessory is a clip that snapsshut to hold the suture ends to close the repair loop.

In yet other examples, the implantable accessory 2200 is an implantableclasp that is able to hold suture ends in place (FIGS. 36A-36C). In afirst position, a top piece 2220 and a bottom piece 2222 of the claspare aligned so that there is a straight channel through which a suturecan slide. Once the repair is appropriately tensioned, one end of theclasp may be rotated so that the suture pathway become tortuous andsmall, thus holding the suture in place.

Another embodiment of an implantable knot tying accessory 2300 is shownin FIG. 37. An implantable toggle 2324 has a configuration where thesuture slides easily through it, and a second where the suture is heldin place. The mechanism could be similar to the toggles on drawstringson clothing, where pushing a button aligns the holes through which thesuture travels. The toggle could have separate lumens each suture, orpotentially a single hole for both sutures.

FIG. 38 shows a structure for bringing together and maintaining tissue.This embodiment includes a one-way sliding mechanism 2426 like a zip tieto hold the meniscus together. One embodiment of this concept uses animplantable, non-suture based material to form a holder 2427 portion ofthe zip tie. Another embodiment uses barbed suture as the incrementalteeth of the zip tie. Another embodiment uses a series of knots tiedinto a suture line as the incremental teeth of the zip tie. Yet anotherembodiment of the holder is the existing suture line, which the barbedsuture or knots is pierced through to keep in place.

Another concept for bringing together and maintaining tissue is a suturewith knots 2500, wherein the suture can also be passed through a loop2511 formed from the suture (FIG. 39). Once the repair is tight, theloop would automatically be pulled tight and shut, keeping the sutureknot from pulling out. A variation of this idea uses a loop formed fromdividing the width of the suture in two. Such a loop could be anywhereon the suture length (FIG. 40), not only at the end of the suture. Theappropriate suture knot/ball is passed through the loop to hold therepair closed. The suture line with knots can also be slid through apre-tied, sliding knot construct such as a girth hitch. When the repairwas appropriately tensioned, the free leg of the knot construct ispulled to cinch down on the suture, and the suture knots keep that linefrom sliding backwards (FIGS. 41A and 41B).

Another embodiment of the knot accessory 2800 is shown in FIG. 42. showsan implant similar to a backpack strap, which uses a tortuous path andmaterial shaping so that it is easy to pull the suture through in onedirection but difficult in the reverse direction.

Another embodiment of the knot accessory 2900 is shown in FIG. 43. Thisdevice includes an outer tube 2920 and an inner tube 2922 that areinitially in an open configuration allowing the sutures to easily slidethrough. To secure the suture in place, the tubes are slid and heldtogether, creating a tortuous path for the suture and preventing themfrom sliding further.

Another embodiment of the knot accessory is shown in FIG. 44. Here asuture bight through a hole 3020 in an implant 3022. The ends of thesuture are passed through the suture bight, and the loop construct istightened.

Another embodiment of the knot accessory 3100 is shown in FIG. 45. Here,adhesive are used to bond the suture lines together, or to bond a sutureknot. One version uses an adhesive activated by aqueous solution. Oneversion delivers the adhesive from an accessory device at the repairsite, and another version delivers the adhesive through a knot pusher.The suture can also be welded together. Methods exist currently to weldthe suture ultrasonically. The welding could be facilitated at the endof a knot pusher/ knot cutter device. In FIG. 45, a mesh/grid material3130 through which the suture is woven. The suture can slide easilythrough the mesh to tighten the repair, until the mesh is tightened,folded, and/or rolled up. In one variation, the mesh starts attached toone end of the suture (see bottom picture below). In another variation,the mesh is a separate piece through which both suture ends are wovenafter stitch delivery through the meniscus.

Another concept described herein is the idea of a doubled-back suture. Adoubled-back suture in the repair to create a stronger knot. Thedoubled-back suture could be achieved by shuttling in the bight ofsuture. Alternately, the doubled-back suture could be created by passinga bight of suture on one needle fire, and passing both free ends ofsuture on the other fire. Another variation uses a knot configurationthat is not traditionally considered a sliding knot using lubricioussuture that enables the knot to be slid. This can result in a moresecure knot in the lubricious suture than would be possible using atraditional sliding knot. This style of knot may be formed by acartridge or accessory device as detailed above. The knot may also beformed at the end of a knot pusher for convenient repair completion.Another variation forms a non-sliding knot around the tip of a knotdelivery device (for example, a knot pusher) such that it is held in anopen and sliding configuration. The knot is then delivered to the repairand released from the knot delivery device, allowing the knot to betightened into a non-sliding configuration to complete the repair loop.One embodiment is a cartridge that attached to the knot delivery device.Another embodiment is a separate accessory device that does not attachto the knot delivery device. Another embodiment is a knot deliverydevice with built-in knot-forming functionality.

In suture-based repair of soft tissue, after suture is passed throughtissue, a knot is typically used to join both ends of the suture tocreate a suture loop. The resultant knot is then cinched to the repairsite and tightened to approximate tissue and complete the repair. Thefollowing disclosure illustrates suture that is preloaded in a suturepasser and configured with a knot prior to use.

FIGS. 46A-46E represent an example of a suture (shown with rope foreasier visualization) with a pre-formed knot bundle at one end. The knotbundle is passed through the tissue at one location, and the knot-freeend of the suture is passed through the tissue at another location. Theknot-free end is then passed through one or more loops formed by thepre-tied knot. The suture is tensioned and the knot is dressed to jointhe two ends of the suture. The knot is tightened to its final positionto complete the repair.

FIGS. 47A-47D show a suture with a pre-tied knot (such as the onedescribed above) positioned/ assembled on top of the cartridge. Thepre-tied knot may be positioned near the distal end of the lower jaw sothat the pre-tied knot can pass more easily out of the cartridge. Afterthe suture ends are passed through tissue, the device is retracted andthe suture is released from the cartridge.

FIGS. 48A-48C show different examples of pre-formed knots with loops tojoin the two ends of the suture. Arrows indicate the passing of sutureinto one or more loops and also pulling of the suture to cinch and/orform the knot.

Similarly, FIGS. 49A-49G illustrate a suture with a pre-formed knotbundle at one end. The knot bundle is passed through the tissue at onelocation, and the knot-free end of the suture is passed through thetissue at another location. The knot-free end is then passed throughmore than one loop formed by the pre-tied knot. The knot-free end of thesuture exits one loop of the knot and then enters another loop of theknot, leaving a tail and a temporary loop. The suture is tensioned andthe knot is dressed to join the two ends of the suture. The knot is sentto its final position. Finally, the suture limb is tensioned to removethe temporary loop and fully secure the knot and complete the repair.

FIG. 50 shows another embodiment for joining both ends of the suture.The suture in this example may have a series of openings at one end ofthe suture. The other end of the suture is woven through the openings tojoin both ends of the suture.

FIG. 51 shows a tapered portion of a suture where the tapered portionhas a smaller diameter than the rest of the suture. The tapered portionof the suture is used to facilitate the passing of the knot-free end ofthe suture through the pre-tied knot when dressing the knot.

FIG. 52 shows another embodiment to facilitate the passing of theknot-free end of the suture through the pre-tied knot when dressing theknot. The pre-tied knot configuration is kept loose/open and the shapeis set through heat or other means. The knot-free is then passed easilythrough pre-tied knot when dressing the knot.

FIGS. 53A-53E illustrate a suture with a knot that is pre-tied around aseparate disposable suture or other cord-like element (suture shuttle).The suture with the pre-tied knot and the suture shuttle are positioned/assembled on top of the cartridge. One end of the suture is passedthrough tissue at one location, and the loop end of the suture shuttleis passed through tissue at another location. The cartridge is removedfrom the suture passer handle and the sutures are released from the topof the cartridge. In FIG. 53B, the suture shuttle is pulled and thesuture tail is passed from the top of the tissue to the bottom of thetissue and through the pre-tied knot to join both ends of the suture. InFIGS. 53C-53E the knot is dressed and sent to its final position tocomplete the repair.

Other variations may include substituting the suture and suture shuttlein the previous example with any of the examples of sutures withpre-tied knots described earlier.

FIG. 54 shows a suture cartridge that is loaded from the top side of thesuture passer's shaft to provide additional space for any of thepre-tied knot or suture shuttle concepts described earlier. Otherelements of the device such as the shaft and clamp components can bedesigned to occupy space lateral to the cartridge to facilitate thisconcept. FIG. 54 also shows a housing 5407 for the pre-tied knot thatcan break away or similarly detach from the cartridge to release thepre-tied knot.

In any of these variations, the knot-free of the suture may be tapereddown to a smaller diameter. This reduces the space occupied by theknot-free end in the cartridge, providing more room for the pre-tiedknot. Thus, any of the variations described herein may also use a suturewith one end tapered down to a smaller diameter. A pre-tied knot with anopen loop may be formed in the small-diameter end, resulting in asmaller pre-tied knot than is possible with the full-diameter suture.The suture ends are first passed through the tissue. Next thefull-diameter, knot-free end is passed through the loop. Then the knotis flipped/ dressed into a configuration that slides over thesmall-diameter end. The knot is then slid past the small-diametersection and to the full-diameter section. The knot is now composed ofonly full-diameter suture, and is tightened to its final position tocomplete the repair.

Other Suture Passers

FIGS. 55A-59B show variations of suture passers that may be used withthe pre-tied knots and assemblies for forming them as described herein.For example, FIG. 55A-55E show a suture passer where a knot-free end ofsuture is initially loaded into the upper jaw, either manually or byattaching a cartridge. The first pass is completed as follows: a needleis fired through the tissue, the needle grabs the suture end from theupper jaw, the needle pulls the suture end down through the tissue, andthe suture end is held in the lower jaw. For the second pass, the needleis fired again to pass the suture end up through the tissue where it iscaptured by the upper jaw. A pre-tied knot at the opposite end of thesuture is then released from the cartridge. The knot is moved off of thesuture passer and onto the knot-free suture end. The suture is tensionedand the knot is dressed to join the two ends of the suture. The knot istightened to its final position to complete the repair.

In another embodiment, one needle retrieves the suture end and anotherneedle passes it back to the upper jaw. In another embodiment (shown inFIG. 56), the needle retrieves a shuttle that is connected to the sutureend so that the shuttle pulls the suture end into the lower jaw. For thesecond pass, the needle can pass either the suture end or the shuttle upthrough tissue where it is captured by the upper jaw.

FIGS. 57 and 58A-58B shows a suture passer that has a length of suturethat is formed into a loose knot configuration and held open in theupper jaw. The ends of a separate repair suture are passed through thetissue and through the open knot, and are captured in the upper jaw. Theknot suture is released from the upper jaw and the knot is tightened/dressed to secure the two ends of the repair suture. The knot is sliddown the repair suture to its final position to complete the repair.

In FIGS. 59A-59B the knot suture is held in the cartridge and thenreleased over the ends of the repair suture.

In any of the embodiments described above, a second suture may be placedabout the repair suture to further maintain and hold the repair suturein place. Also, in any of the embodiments described above, the knottying accessory can be provided for as a kit. It may also beadvantageous for the kit to be sterile.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims. The examples and illustrations included herein show, by wayof illustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A suture having a pre-tied knot, the suturecomprising: an elongate flexible length of suture material having afirst end and a second end; a pre-tied knot body formed from the suture,material at a region near the first end of the suture, the pre-tied knotbody having one or more loops of the suture material, wherein each loophas at least one crossing point; and a leader snare formed of a lengthof linear and flexible material, wherein the pre-tied knot body is tiedaround the leader snare so that the leader snare passes through the oneor more loops of the knot body, wherein a bight region of the leadersnare extends from a first end of the knot body and a pull tail extendsfrom a second end of the knot body, wherein the knot body and leadersnare are sufficiently flexible and narrow of profile to be pulledthrough a tissue behind a tissue penetrator.
 2. The suture of claim 1,wherein the pre-tied knot body comprises three or more loops of suturematerial.
 3. The suture of claim 1, wherein the leader snare is formedof a second suture material.
 4. The suture of claim 1, wherein the bightregion of the leader snare extends towards the second end of the sutureand the pull tail of the leader snare extends towards the first end ofthe suture.
 5. The suture of claim 1, wherein the material forming theleader snare has a larger diameter than the suture.
 6. The suture ofclaim 1, wherein the knot body is configured to slide along the lengthof the suture.
 7. A method of passing a suture through a tissue, themethod comprising: placing a first jaw of a suture passer on one side ofa tissue to be sutured; placing a second jaw of the suture passer on theopposite side of the tissue to be sutured; passing a knotted end of asuture through the tissue from the second jaw to the first jaw, whereinthe knot is located at or near the distal end of the suture; and holdingthe knot in the first jaw.
 8. A knot tying accessory comprising: adevice body that is configured to open to expose an interior space,wherein the interior space defines a convoluted pathway that crossesover itself at multiple locations within the device body; a guide threadwith a capture loop at a first end of the guide thread, wherein theguide thread is threaded into the convoluted path of the device bodysuch that the first end of the capture loop is situated at a firstlocation at a first opening outside of and adjacent to the device bodyand able to receive a first end of a suture; a first pull tab coupled toan intermediate position on the guide thread that extends out of thedevice body at a second location at a second opening on the device body;a third opening at a third location on the device body wherein when thecapture loop has exited the device body at the second location, thecapture loop is pulled to the third opening and wherein the capture loopis able to receive a second end of a suture; and a second pull tab at asecond end of the guide thread, wherein the second end extends out ofthe device body at a fourth location from a fourth opening on the devicebody.
 9. The knot tying accessory of claim 8, wherein the convolutedpathway is planar.
 10. The knot tying accessory of claim 8, wherein theconvoluted pathway comprising a series of connected curves, the seriesof connected curves having angles that are greater than 90 degrees. 11.The knot tying accessory of claim 8, wherein the device body furthercomprising a series of channels that define the convoluted pathway. 12.The knot tying accessory of claim 8, wherein the device body furthercomprising a series of protrusions that define the convoluted pathway.13. The knot tying accessory of claim 8, wherein the device body furthercomprising a combination of a series of channels and a series ofprotrusion for defining the convoluted pathway.
 14. The knot tyingaccessory of claim 8, wherein the capture loop comprising a sliding knotfor coupling to a suture end.
 15. The knot tying accessory of claim 8,wherein the capture loop comprising a coupler for coupling to the sutureend.
 16. The knot tying accessory of claim 15, wherein the coupler forcoupling to the suture end is a clip.
 17. The knot tying accessory ofclaim 8, wherein the capture loop has an open state such that a bight ofsuture may be threaded through; and a closed state, such that thecapture loop is able to maintain the bight of suture as it travels theconvoluted pathway through the interior of the device body.
 18. The knottying accessory of claim 8, wherein the capture loop and the guidethread comprising, a material having a frictional coefficient of 0.5 orless.
 19. The knot tying accessory of claim 8, wherein the first and thesecond pull tab each comprising detachable couplers for removableattaching to the guide thread at the second and the third location atthe device body.
 20. The knot tying accessory of claim 8, wherein theoverall dimensions of the first and the second pull tabs are greaterthan the second and the third opening on the device body, such that thefirst and the second pull tabs cannot be pulled into the interior spaceof the device body.
 21. A method of tying a suture knot comprising:threading a first leg of a suture through a capture loop disposed at afirst end of a guide thread, wherein the capture loop is disposed at afirst location on an openable device body and the guide thread has beenlaced through a convoluted path defined within an interior space of theopenable device body; pulling a first pull tab disposed on the guidethread at a second location on the device body to draw the first leg ofthe suture through a first portion of the convoluted pathway within thedevice body until the capture loop exits the interior space of thedevice body at the second location; releasing the first leg of thesuture from the capture loop; threading a second leg of the suturethrough the capture loop; pulling a second pull tab disposed on theguide thread at a third location on the device body to draw the secondleg of the suture travel through a second portion of the convolutedpathway within the device body interior space until the capture loopexits the interior space of the device body at the third location; andopening the device body to remove the suture knot from the device bodyand pushing the suture knot towards tissue to he sewn together.
 22. Themethod of claim 21, further comprising cinching or clamping the firstleg of the suture within the capture loop so that it does not detachfrom the capture loop when pulled before pulling the first tab.
 23. Themethod of claim 21, further comprising cinching or clamping the secondleg of the suture within the capture loop before pulling the second pulltab.
 24. The method of claim 21, wherein the first leg and the secondleg of the suture are a first end and a second end of the same piece ofsuture.
 25. The method of claim 21, wherein the first pull tab can onlybe pull the guide thread from one side.
 26. The method of claim 21,wherein the guide thread may he threaded in a variety of patterns withinthe interior space of the device body.
 27. A knot typing accessorydevice comprising: a device body configured to hold a portion of athread in a pattern within the device body, wherein the thread has afirst end and a second end, the first end and the second end of thethread able to couple with a first end and a second end of a suture; andat least one pull disposed on the thread, such that when the at leastone pull is coupled to the first or the second end of the suture ispulled, the first end or the second end of the suture is pulled throughthe pattern to form a knot between the first and the second end of thesuture.
 28. The device of claim 27, wherein the device body comprises acartridge having at least one pull, wherein the cartridge is coupled toa knot pusher.
 29. The device of claim 27, wherein the device bodycomprises a cartridge having at least one pull in a loose knotconfiguration disposed around a shaft of a suture passer.
 30. The deviceof claim 27, wherein the device body comprising a cartridge able to passa preloaded suture and able to form a loose knot configuration at thepull.
 31. The device of claim 27, wherein the pull comprises a snare.32. The device of claim 27, wherein the device body is a tubular bodyhaving the pull configured as a snare that is wound around the tubularbody in a knot bundle configuration able to receive a piece of suture.33. The device of claim 27, wherein the device body is a tubular bodyfurther comprising an array of protrusions arrange about the tubularbody able to maintain different portions of the snare allow formation ofportions of the slide-able knot in discrete phases.
 34. The device ofclaim 33, wherein the tubular body is collapsible allowing easy releaseof the slide-able knot.
 35. The device of claim 27, wherein the devicebody further comprises a rotatable piece, a series of positioningguides, and a winding tool for positioning the length of suture into theknot pattern desired.
 36. The device of claim 27, wherein the devicebody is a three-dimensional geometric shape configured to receive thelength of suture for threading the length of suture into the knotpattern desired, and collapsible to release the knot pattern formed. 37.The device of claim 27, the device further comprising a bearing and aseries of guides Able to receive the bearing, the bearing having acoupler for coupling and drawing the length of suture through the guidesfor forming the knot.
 38. The device of claim 27, wherein the devicebody further comprising cams.